CSL

CSL Behring ist ein weltweit führendes Biotech-Unternehmen, das sich seinem Versprechen verpflichtet hat, Leben zu retten. In Bern entwickeln und vertreiben wir mit über 1’800 Mitarbeitenden lebensrettende Therapien für Menschen mit schweren und seltenen Krankheiten weltweit. Für unseren Bereich Visuelle Endkontrolle innerhalb des Departements Produktion am Standort Bern suchen wir eine/n Pharma-Mitarbeiter/in (befristet für 12 Monate) In dieser Tätigkeit sind Sie ein wichtiger Teil unseres Produktionsprozesses und für die folgenden Hauptaufgaben zuständig: Manuelle bzw. halbautomatische visuelle Kontrolle von Endprodukten und MediafillsUmladen der Flaschen auf Palletten sowie Einlagerung der FlaschenProtokollieren der ausgeführten ArbeitenBedienen von Maschinen und GerätenAusführen von Reinigungsarbeiten an der AnlageKontinuierliches Einhalten der Hygienevorschriften Um die beschriebenen Tätigkeiten erfolgreich erfüllen zu können, bringen Sie die folgenden Kompetenzen mit: Engagierte und teamfähige Persönlichkeit mit offenen und partnerschaftlichen KommunikationsfähigkeitenExakte und saubere ArbeitsweiseHohe Konzentrationsfähigkeit und gutes SehvermögenGute Deutschkenntnisse (in Wort und Schrift)Bereitschaft zu verschobenen Arbeitszeiten und Einsätzen am Samstag Fühlen Sie sich angesprochen? Dann freuen wir uns auf Ihre Online-Bewerbung. Ihre Bewerbung sollte ein Motivationsschreiben, einen Lebenslauf/CV sowie Arbeitszeugnisse und Kopien von Diplomen in der Originalsprache und/oder relevante Transkripte beinhalten. Bitte fügen Sie Ihre Dateien, inklusive CV, zu einem Dokument zusammen. CSL Behring verpflichtet sich dem Prinzip der Chancengleichheit. Our BenefitsWe encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL. About CSL BehringCSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring. We want CSL to reflect the world around usAs a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Behring!

The Biostatistician in Japan provides statistical contribution to a clinical development program, including e-data and CDISC for submission to PMDA. The Biostatistician implements statistical strategies for clinical trials and regulatory submissions, and is accountable for statistical deliverables. The position is to collaborate with all therapeutic areas. More specifically: 1 - Support development of components (CSR, CTD, CDISC, e-Data, DSUR) for submission to PMDA and interact with global and local team 2 - Perform quality control of the key e-data and CDISC deliverables 3 - Support Biostatistics interactions with PMDA as part of the response/inspection team. 4 - Provide Biostatistics support (global studies including Japan, Japan standalone studies, PMS) in study data collection, data analysis, reporting, and submission preparation in close collaboration with global DM and Statistical Programming 5 - Conduct ad hoc statistical analysis, including surveys utilizing Medical Information Databases (per PMDA requirement) 6 - Be accountable for timely completion and quality of the statistical analysis plan 7 - Collaborate with, direct or monitor programmers and/or statistical teams under supervision. 8 - Perform statistical research or assist in evaluating statistical methodology related to drug development 9 - Implement sound statistical methods related to drug development 10 - Be responsible for result accuracy in study report and regulatory submission documents including archiving documents Education PhD or MS in Biostatistics, Statistics, or related fields Experience MS with 3 years of experience in drug development; or PhD degree Competencies Advanced knowledge and training in applications of statistical methodologiesStrong interpersonal and communication skills (native Japanese, verbal and written in English)Ability to collaboratively work in matrix environmentExperience in CDISC, Data Management preferredGood working knowledge of SAS and/or R Our BenefitsWe encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL. About CSL BehringCSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring. We want CSL to reflect the world around usAs a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Behring!

Bist Du auf der Suche nach einer Lehrstelle für den Sommer 2024 und möchtest Deine Erfahrung gerne in der Pharmaindustrie sammeln? Dann bieten wir dir die Möglichkeit dazu. Du sprichst fliessend Deutsch und hast Grundkenntnisse in Englisch. Du hast ein gutes Flair für Zahlen und bist interessiert in der Chemiebranche zu arbeiten? Dann suchen wir Dich als Lernender Laborant/-in EFZ Fachrichtung Chemie (m/w/d) Dein Aufgabengebiet: Laborantinnen und Laboranten EFZ Fachrichtung Chemie arbeiten in der Forschung, Entwicklung, Produktion und Qualitätskontrolle. Sie planen Versuche und Arbeitsabläufe, bereiten diese vor und führen diese durch. Analysendaten werden aufbereitet, dokumentiert, Methoden und Prozesse werden an Produkte angepasst und sie arbeiten bei der Weiterentwicklung und Methodenentwicklung mit. Sie sind für die effiziente und sichere Organisation im Labor verantwortlich. Das bringst du mit: Mindestens Schulniveau Sekundarschule oder höhere Schulstufen Du bist neugierig und hast Freude an naturwissenschaftlichen Fragestellungen wie Biologie, Chemie, Physik, Mathematik und Technik. Du arbeitest gerne im Team, beteiligst dich aktiv an Diskussionen und hast Spass daran eigene kreative Lösungsansätze zu finden, kannst aber auch selbständig und konzentriert für dich arbeiten Du bringst Kenntnisse in Naturwissenschaften mit (Chemie, Physik und Mathematik) In Mathematik bist du sattelfest (Notendurchschnitt ≥ 4.5) Sehr gute Deutschkenntnisse in Wort und Schrift sind für diese Position ein Muss (Muttersprache oder Niveau B2) Du besitzt Grundkenntnisse in Englisch Zuverlässigkeit, eine gute Beobachtungsgabe und gute manuelle Fertigkeiten sind drei wesentliche Merkmale die du mitbringen solltest. Deine punktest durch eine hohe Aufnahmefähigkeit Das erwartet dich bei CSL Vifor: Ein angenehmer Arbeitsplatz und eingespieltes Team Du kannst Deiner Kreativität freien Lauf lassen Eine Mitarbeiterkantine um sich zu verpflegen Moderne Labore und Einrichtungen stehen Dir Täglich zur Verfügung Am Ende Deiner Berufsausbildung erwartet Dich eine erfolgreiche Ausbildung zum Laborant/-in EFZ Fachrichtung Chemie Fühlst Du Dich angesprochen und bist Du bereit, um eine tolle Herausforderung anzutreten? Dann bewirb dich jetzt für Deine Karriere im 2024. Deine vollständige Bewerbung enthält folgende Dokumente: Lebenslauf Motivationsschreiben Zeugnisse der letzten zwei Semester Stellwerktest, Check S2, Multicheck, je nach Kanton About CSL ViforCSL Vifor aims to become the global leader in iron deficiency and nephrology. The company is a partner of choice for pharmaceuticals and innovative patient-focused solutions across iron, dialysis, nephrology and rare conditions. CSL Vifor strives to help patients around the world with severe, chronic and rare diseases lead better, healthier lives. It specializes in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision patient care. For more information, please visit viforpharma.com We want CSL to reflect the world around usAs a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Vifor!

For our Recombinant Product Development department in Marburg, we are looking for a Intern Nanoparticle Downstream Processing (m/f/d) - R-207982 Role We have an opportunity available for an Intern to join the R&D team at CSL Behring Innovation in Marburg. Our team focuses on delivery of new biotherapies to treat serious medical conditions. You will join a global network of scientists and engineers who develop and manufacture recombinant proteins, vaccines, and cell-based gene therapies for pre-clinical and human clinical trials. Main Responsibilities and Accoutabilities: Conduct experimental studies involving the purification and filtration of nanoparticles Operation of equipment pertaining to the downstream processing of nanoparticles Work and collaborate closely with other concerned members. Documentation and reporting of experimental studies and activities. Analysis of experimental data. Experience in the following areas is an advantage: (Tangential Flow) Filtration or other membrane filtration processes Surface chemistry Data analysis Qualifications & Experience: A University Degree in a relevant field of Science (e.g. Bachelor of Science in Life Sciences) English Level 2 Our BenefitsWe encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL. About CSL BehringCSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring. We want CSL to reflect the world around usAs a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Behring!

CSL Vifor is a global partner of choice for pharmaceuticals and innovative, leading therapies in iron deficiency, dialysis and nephrology & rare disease. We specialize in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision healthcare, aiming to help patients around the world lead better, healthier lives. We are looking for a GRA CMC Lead for Small Molecules and Complex Non-Biologic Drug Products to join us at our office in Zurich or St. Gallen. In this position, you will be directly reporting to the Head GRA CMC. We are offering a flexible and hybrid working model (#LI-Hybrid). Position Purpose: The GRA CMC Lead provides tactical and strategic regulatory leadership and global oversight for all CMC regulatory aspects related to small molecules and complex non-biologics. The GRA CMC Lead is the subject matter expert for small molecules and complex non-biologics and the primary regulatory interface to relevant global technical expert functions. He/she oversees and interprets relevant existing or new regulatory requirements, evaluates draft guidelines, writes impact assessments, leads gap analysis and proposes solutions and strategies to remediate risks. The GRA CMC Lead provides complete, accurate and timely regulatory CMC strategies, submissions, advice, impact assessments and risk mitigation proposals to enable successful regulatory outcomes and facilitate balancing of business objectives and current health authority expectations. The GRA CMC Lead provides effective communications between Regulatory Affairs CMC and relevant stakeholders within GRA as well as across and outside of the organization, as evidenced by the successful achievement of CMC regulatory milestones and deliverables according to project plans, and by the level of stakeholder satisfaction with the support provided by the group. Responsibilities: Manages large team with average complexity that can include multiple teams led by Managers and/or Supervisors Focus on tactical and operational plans with short-to mid-term focus (e.g., 1-2 years) Problems faced are often complex and require extensive investigation and analysis Requires ability to influence others to accept practices and approaches, and ability to communicate outside own functional areas Oversees and directs regulatory activities for new and mature products to ensure alignment and compliance with local and regional registration requirements as well as with company policies. Develops and implements regulatory product strategies. Establishes team priorities, goals and objectives while monitoring development and execution of tactical work plans to accomplish goals and objectives. Coordinates intracompany activities to obtain and compile information for submission to Regulatory Agencies regarding licenses and registrations. Interfaces directly with Regulatory bodies worldwide in obtaining product registration/licensure. Implements programs and procedures necessary to achieve compliance with new regulatory requirements. Develops consistent roles and work processes across the team, fostering adoption of technology to further improve consistency and efficiency of overall team. Develops and maintains good working relationships with all stakeholders. Maintains an intimate knowledge of relevant CMC regulations Provide strategic vision, leadership, expertise and oversight in all CMC regulatory aspects and activities for CSL’s small molecule and complex non-biologic drug product product portfolio, including driving Non-Biologics Complex Drug Product’s principles within and outside the organization, with main focus on CMC activities. Your Profile Advanced degree in a Life Science or Business (Master, PhD, MBA) 10+ years regulatory experience in the pharmaceutical industry, Regulatory experience preferred Demonstrated familiarity with and ability to interpret the Code of Federal Regulations and other FDA, EU, CA, AU and ICH documents to prepare regulatory / product development strategies At least 5 years leadership experience Fluent English and good level of German About CSL ViforCSL Vifor aims to become the global leader in iron deficiency and nephrology. The company is a partner of choice for pharmaceuticals and innovative patient-focused solutions across iron, dialysis, nephrology and rare conditions. CSL Vifor strives to help patients around the world with severe, chronic and rare diseases lead better, healthier lives. It specializes in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision patient care. For more information, please visit viforpharma.com We want CSL to reflect the world around usAs a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Vifor!

For our Viral Vector Process Development department in Marburg, we are looking for a Senior Manager – Viral Vector Downstream Process Development (m/f/x) R-209087(Fulltime / permanent/ non-tariff) Role Join CSL Behring enthusiastic, innovative, collaborative viral vector process development team and contribute to the overall success of our novel viral vector therapy approaches. We seek an energetic, goal-oriented, and innovative candidate for our growing viral vector process development (VVPD) team to provide support for process development of lentiviral vectors. As a Senior Manager joining the Viral Vector Process Development team within Biopharmaceutical Product Development (BPD), you will be responsible for downstream process development activities for a variety of therapeutic candidate. You will report to the Director Viral Vector Process Development. Main Responsibilities and Accountabilities: Your main responsibility will be to manage the gene therapy downstream process development team. In this role you will be responsible for the development of experimental study designs. Another focus will be the participation in local and global projects and the coordination of development/research projects as project scientific coordinator.You will be responsible for the viral vector process development department to support tech transfers to external partners as well as managing process development activities at external partners.As an expert for specific processes and devices you will gather information of external suppliers and collaboration partners.You will support the creation and maintenance of records and technical documents (including operating procedures, test- or process protocols and reports) within internal documentation systems and contribute to the submission of regulatory documents You will be responsible for laboratory safety and GMO safety within the viral vector process development team. Qualifications & Experience: Postgraduate degree (preferably MSc or PhD) and/or extensive experience in relevant discipline.Minimum of 5 years' relevant industry experience and/or equivalent experience in a relevant academic environment.Track record of scientific achievement in relevant Life Sciences discipline.relevant experience in downstream process development preferably in the pharmaceutical industryKnowledge in suspension bioreactors and viral vector process development are a plusexperience in people managementExcellent communication and presentation skills in English, advanced German skills are a plus Marburg, 17.08.2023 CSL Behring Innovation GmbH Human Resources Requisition: R-209087 Our BenefitsWe encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL. About CSL BehringCSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring. We want CSL to reflect the world around usAs a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Behring!

CSL Vifor is currently undergoing unprecedented growth and portfolio expansion within rare diseases, Nephrology and Cardiorenal therapeutic areas. A permanent global position in the Global Regulatory Affairs Labelling team has arisen. Which can be based at any of our CSL R&D Hubs (Maidenhead UK, Amsterdam, NL, Bern, CH, Zurich, CH, KOP, PA or Waltham, MA) As part of our integration with CSL this role will be truly global and cross modality including speciality care, vaccines, plasma products, gene therapies and recombinant proteins, this role would span all products and therapeutic areas (Vaccines, Immunology, Haematology, Respiratory and Transplant, Cardiorenal, Nephrology) across the group of companies. This is an excellent opportunity to gain global experience within Global labelling in a high performing team at a time when multiple new drug development programs are ongoing. You will make significant contributions within regulatory affairs in a pharmaceutical or biotechnology setting and lead labelling activities such as CCDS creation/update and regional/local label development for major markets. This opportunity would suit someone who is currently working in regulatory labelling and is committed to this discipline. Responsibilities PRIMARY: Strategic Labelling Develop and provide labelling strategies impacting the CCDS (company position) and product positioning in major marketsLead/manage CCDS creation and maintenance in collaboration with other line functions such as clinical development, safety, clinical pharmacology, medical affairs and commercialLeading GRA Labelling quality initiatives Plan CCDS roll-outs and strategic implementation into regional/local labels e.g., US PI, SmPC, PILsSupport CCDS implementation into local labelling based on local regulationFacilitate and manage deviations of regional/local labels from the CCDSFulfil Global Labelling strategist role and contribute to team activities as per mandated processesCollaborate with regional regulatory in responding to Health Authority questions on product information/labelling-related questionsInterface with key stakeholders across the company e.g., Global Regulatory Leads, Regional Regulatory Leads, Safety, Clinical Development, Medical Affairs, Commercial, Legal etc.SECONDARY: Operational Labelling & Packaging (all regions) Maintenance of specific product labelling related information in department databases, systems and external processes (e.g. PSMF, GLS, eDMS) and relevant tracking and planning systems (Trackwise)Validation/record of product information documents, e.g. SmPC, PIL, packagingCollaborate and support global labelling operations with artwork development and downstream implementation activitiesMinimum Requirements University degree in Life Sciences or Pharmaceutical related fieldsExperience (5-8 years) working in regulatory affairs, safety or supply chain specifically with labellingExcellent command of English – both spoken and written. Expertise in the use of basic IT systems & tools.Preferred Requirements Higher university degree (Masters) in a relevant life sciences discipline, or specialised degree (Pharmacist).Basic knowledge of drug development & labelling related issuesFamiliarity with either pharmacovigilance concepts and practices, or with pharmaceutical supply chain processesFluency in German or French About CSL ViforCSL Vifor aims to become the global leader in iron deficiency and nephrology. The company is a partner of choice for pharmaceuticals and innovative patient-focused solutions across iron, dialysis, nephrology and rare conditions. CSL Vifor strives to help patients around the world with severe, chronic and rare diseases lead better, healthier lives. It specializes in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision patient care. For more information, please visit viforpharma.com We want CSL to reflect the world around usAs a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Vifor!

Are you an experienced biopharmaceutical professional looking for a chance to make a positive impact on human health in a dynamic and growing environment? If so, CSL is looking for you! We are seeking a Principal Scientist to represent the Global Pathogen Safety Support team for our Illinois manufacturing site. In this role you will work as part of a team responsible for providing pathogen safety support to the North American (NA) CSL Behring manufacturing and development site (Bradley, IL) and providing global support on pathogen safety across the CSL organization. You will be responsible for becoming familiar and knowledgeable with Pathogen Safety (PS) studies supporting developmental and licensed products manufactured at the CSL Behring Illinois manufacturing site. You will also become familiar with routine PS activities required to support the broader CSL organization including assembling data and supportive documentation, preparing spreadsheets, and analyzing data, conducting scientific literature searches, writing deviation and change risk assessments, and performing facility risk assessments. You will work with partners across the CSL Behring organization (with interface functions such as Process Development, MS&T, Quality Assurance, Clinical, Regulatory, Pharmacovigilance, Commercial, Corporate Communications) and will draft risk assessments, position papers, presentations, training materials, talking points, and decision tree matrices in support of the business needs. Due to the global aspects of the position, you may periodically be required to participate in global telcon meetings outside of local business hours. Responsibilities: • Be an effective contributor to the Global PS Support Team. Actively participate in meetings and seek innovative solutions to provide excellent customer support and create efficiencies across the global PS organization. • Organize and assemble data, supporting documentation, and conduct scientific literature searches. Create tables, spreadsheets, decision tree matrices, and analyze data. • Prepare and update PS documentation and regulatory submission documents for plasma, recombinant, and gene therapy products. Draft risk assessments (both local and global), position papers, decision tree matrices, presentations, training materials, talking points, data analyses in support of the business needs. • Actively participate and represent GPS on cross-functional project teams and global project teams. Deliver GPS strategy by creating a respectful and open communication environment. Requires working periodically outside of local business hours. • Lead local and global Pathogen Safety driven initiatives. Influence peers and leaders to implement state of art pathogen safety strategies across different therapeutic platforms. Qualifications: Minimum of Masters (or BS/equivalent with appropriate experience) in Virology, Biochemistry, Biology, or related field Minimum 5 years of experience in biologicals R&D or Quality Management Demonstrated ability to work across sites and across international teams is desired. Basic knowledge of biochemistry and/or virology: Strong scientific training and analytic processing skills. Our BenefitsCSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals. Please take the time to review our benefits site to see what’s available to you as a CSL employee. About CSL BehringCSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring. We want CSL to reflect the world around usAs a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Behring!

For our Pharmacology/Toxicology department we are looking for a Scientist - Pharmacology, Cardiovascular & Metabolic (m/f/x) – R-213070 (Fulltime / Permanent/ Tarif) Role As a member of the In Vivo Pharmacology (IVP) Unit, the Scientist - Pharmacology (CV&M) is responsible for planning, coordinating, executing, and reporting of in vivo and in vitro pharmacology studies of regulatory relevance within the therapeutic area of Cardiovascular and Metabolic (CV&M) diseases. The activities will furthermore involve setting up animal models of disease, supervising PhD students (if required) and laboratory technicians (task-based) and working in matrix teams across different functional areas. The Scientist -Pharmacology, CV&M will act as pharmacology representative in global cross-functional research and development teams and will be responsible for authoring and reviewing the non-clinical pharmacology sections of national and international regulatory submission documents. Main Responsibilities and Accountabilities: Plan, initiate and perform pharmacology studies, including proof of efficacy, dose range and time course studies, within the CV&M Therapeutic AreaCoordinate and report preclinical pharmacological studies (in vivo, ex vivo and in vitro) conducted internally or in collaboration with external sites at the highest levels of scientific integrity; thereby supporting characterization of drug candidatesEstablishment of new animal models of disease (incl. writing of required ethics applications) and support the identification and generation of biomarker data.Actively collaborate with and contribute to global, cross-continental project teams; and parties within and outside of own job functionClose interaction/alignment with other internal stakeholders and partners to develop and deliver on the non-clinical pharmacology strategy and objectives within the CV&M Therapeutic AreaSupport the preparation of national and international regulatory submissions Provide scientific expertise and guidance in the application of relevant technology platform to research and product development activities.Ensure high quality application of existing and novel technology platforms in order to support designated project objectives Experience in the following areas is an advantage: Experience with regulatory processes in the pharmaceutical industryExperience with echocardiography and telemetry is a plusPrevious completion of a relevant FELASA course is desired Qualifications & Experience: A University Degree in a relevant field of Science (e.g. Bachelor of Science in biology, cardiovascular physiology or pharmacology) Hands-on experience in relevant in vivo models and laboratory techniques.English Level 2, fluent in German 4-5 years of relevant experience Marburg, 05.09.2023 CSL Behring Innovation GmbH Human Resources R-213070 Our BenefitsWe encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL. About CSL BehringCSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring. We want CSL to reflect the world around usAs a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Behring!

For our Plasma Product Development department in Marburg we are looking for a Lead of Data Management and Data Governance (m/f/x) R-213923 (Fulltime/permanent/non-tariff) Role The Head of Data Governance and Data Management in Plasma Product Development plays a pivotal role in ensuring the integrity, quality, and security of data throughout the Plasma Product Development lifecycle. This position offers a unique opportunity to shape data governance and data management strategies, leverages data-driven insights to optimize bioprocesses, and drives innovation in the biopharmaceutical industry. The successful candidate will contribute to the organization's growth and success by enabling effective data governance practices, fostering data-driven decision-making, and ensuring compliance with data integrity and regulatory requirements. Main Responsibilities and Accountabilities: As part of our digital transformation strategy this role will be responsible to develop and implement a data management and governance framework specific to Plasma Product Development, including guidelines and best practices to ensure that our data is captured and organized with highest quality to support bioprocess development and product quality enhancementDrive the development and the implementation of a global data model for Plasma Product Development which defines the logical and physical structure for our data to simplify data processing and utilization across all departments to facilitate the development of a strong culture of data-driven decision-makingLead efforts to harmonize and standardize data management practices across different Plasma Product Development sites and teams globally to provide guidance for our citizen developers who translate business requirements into data workflows and the development of new solutionsCollaborate with lab scientists, data scientists, and IT teams to ensure that effective data infrastructure, systems, and tools are in place to enable efficient data capture, analysis, and visualizationProvide guidance on suitable data science and statistical approaches to drive decision making and leverage the value of our dataCollaborate with cross-functional stakeholders (IT, Research, etc.) and senior leadership to identify and understand data needs, define data requirements, and establish data quality standards and metrics. Promote cross-functional collaboration and alignment on data-related initiatives and priorities across R&DLead and support data management training programs to enhance data literacy and promote awareness of data management best practices among Plasma Product Development teams Qualifications & Experience: Ph.D. or Master's degree in a relevant discipline (e.g. LifeScience, Biotechnology, Statistics, Biochemistry, Chemical Engineering, or similar) or a related field. A combination of education and significant industry experience will also be consideredMinimum of 6 years of experience in data management, data science, or data analytics, preferably in the biopharmaceutical or biotechnology industryStrong expertise in data governance principles and data management best practices particularly in the context of laboratory environmentsExperience working with complex, heterogenic, or large datasets, data integration, data analytics, and data science in the context of biopharmaceutical research and development. Good knowledge in statistics is a plusIdeally knowledge of bioprocess development principles, methodologies, and data requirements, including process optimization, process scale-up, and product characterizationProven track record of driving data initiatives and delivering successful data-driven projectsAbility to work in a global and matrixed organization, collaborating with diverse teams across different locations and time zones Marburg, 07.09.2023 CSL Behring Innovation GmbH Human Resources Requisition: R-213923 Our BenefitsWe encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL. About CSL BehringCSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring. We want CSL to reflect the world around usAs a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Behring!

Reporting to the Sr Director Clinical Development Operations, Global Feasibility and Start-up Support, you will provide start-up execution options to be evaluated by the Study Execution Teams (SET). You will lead important study startup activities for Clinical Development (CDO) including: Delivering detailed program and study start-up and site activation execution plans to support SET leaders.Determining appropriate base and surge resource models for functions supporting startup-activities; enable line of sight with partner functions and CROs regarding the timeline for surges in the CSL clinical portfolio to ensure adequate resources are in place.Identify gaps in the intelligence and problem solve to fill these gaps over time through novel methods such as patient-based resource, EMR partnerships to identify participants. Role and Responsibilities: Accountable and responsible for ensuring that start-up systems and standards are set-up and implemented consistently across product portfolios.Accountable and responsible for defining and developing effective study start-up processes with the delivery of site activation as per the integrated feasibility and operations strategy plan.Accountable and responsible to build a knowledge platform that can capture intelligence for current and future use and that can help to clarify complex data into accurate and clear messages to facilitate informed business decisions.Responsible for leading and contributing to the data driven methodology for ensuring that the start-up and site activation strategy is ed in the incorporated in the integrated feasibility and operational strategy plan.Responsible for line management, mentoring and developing the study start-up team as per CSL values and lead by example continuous improvement.Responsible for building partnership with the clinical development team (CDT), clinical development operations (CDO) and study execution teams (SET) to optimize study start-up efficiency.Driving study start-up initiatives to implement innovative solutions for quality-by-design study start-up and execution accuracy.Maintaining a working knowledge of current and new industry practices/trends and global regulations governing the clinical trial business. Background education and past experiences: Master in clinical research and process management with a strong background in clinical OperationsPast experiences in pilot plants/industrial start up in pharmaceutical /Clinical Research Organization is key to succeed in this position.Extensive experience (>10years) in clinical operations project management, with a focus on study start-up activities and site activation.Extensive expertise in study startup tools and systems, leading and driving key principles of start-up strategies is a must.Strong ability to manage a team of experts.Extensive expertise in clinical trial regulatory environment in multiple regions (EU, NA, APAC, LATAM) to contribute and leverage knowledge and insights to interpret feasibility insights and propose a site activation process in function of the operational readiness strategy is a must.Ability to clarify complex data analyses into accurate and clear messages to facilitate informed business decision.Experience in line management and working in a global matrix model. Our BenefitsWe encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL. About CSL BehringCSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring. We want CSL to reflect the world around usAs a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Behring!

We are seeking an Intern to join our R&D Global Regulatory Affairs Region Europe Team, who is interested and willing to learn, develop and grow within our organization. In your 6-12 months internship you will have the opportunity to work in the Region Europe and cross-functionally in Global Regulatory Affairs, developing a thorough understanding of European regulations and guidelines pertaining to registration of medicinal products and medical devices. You will provide support in the preparation of new marketing authorizations and variations applications in the EU and other countries, as applicable, conduct searches on new or under revision regulations and guidelines and support regulatory impact assessments. After your internship, you will have gained a broad range of practical experience in Regulatory Affairs that will equip you at best for your next role in the regulatory field. Responsibilities:You will develop knowledge on European regulations and guidelines pertaining to registration of medicinal products and medical devicesYou will support impact assessments of new or under revision regulations and guidelinesYou will support new marketing authorisation and variation applications in the EU and other countries, as applicableYou will build and maintain good working relationships with health authorities and other key internal stakeholders (e.g., in R&D and Commercial)You will be coached and supervised by a senior Regulatory professional Qualifications:You have minimum university degree in natural sciences (BSc, MSc, or equivalent)You may have additional training in Regulatory AffairsYou are fluent in English, written and spokenYou have excellent organizational skillsYou are a strong self-starter and a good team player Our BenefitsWe encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL. About CSL BehringCSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring. We want CSL to reflect the world around usAs a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Behring!

We are hiring! Join our Research group in Zurich - Schlieren as the new Head of the Iron Metabolism Team. In this role you will be leading a team of experts, focusing on developing innovative drugs in the field of iron metabolism. You will oversee the day-to-day operations of the team and contribute to workforce planning and the conception of project ideas. The successful candidate will be part of the leadership team and report to the Head of Research Zurich. Key Responsibilities: Leadership and Development: Competently guide and nurture the growth of our Iron Metabolism group. Foster career development, mentoring, and efficient team operations. Cutting-Edge Knowledge: Stay at the forefront of the latest scientific advances and technologies relevant to iron metabolism, oral drug formulation, and hematological diseases to support research projects. Strategic Vision: Shape and execute the Iron Metabolism research strategy, expanding our capabilities, and workforce skills. Contribute to the development and implementation of a globally aligned site strategy as part of the Research Zurich Leadership team. Innovation: Support ongoing projects and identify novel (internal or external) project opportunities with a particular focus on the therapeutic areas of Hematology as well as of Cardiovascular and Metabolic diseases. Global Representation: Represent CSL Research on global project and strategic teams. Efficiency and Budget: Ensure cost efficiency within the Iron Metabolism group. Oversee budgets for projects and infrastructure investments. Collaborations: Foster collaborative relationships with CROs and external academic partners. Communication: Effectively communicate project activities to both internal and external stakeholders. Qualifications and Skills: We're looking for a dedicated, science-driven team player with the following qualifications and skills: Education: A postgraduate degree (PhD or MD/PhD) and over 8 years of industry experience or equivalent experience in a relevant academic environment. Scientific Expertise: Strong scientific background and high-impact publication track record in Hematology, ideally with expertise in the pathomechanisms of benign hematological diseases and adjacent disorders with dysregulated iron metabolism Drug Development: Profound knowledge of the industrial drug development process, experience in developing oral drug formulations, and working with CROs and academic collaborators. Team Player: Experience working in cross-functional, multicultural, global teams. Communication: Excellent English communication skills (knowledge of German is a plus). Our BenefitsWe encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL. About CSLCSL is a leading global biotechnology company with a dynamic portfolio of life-saving medicines, including those that treat haemophilia and immune deficiencies, as well as vaccines to prevent influenza. Since our start in 1916, we have been driven by our promise to save lives through innovation. Learn more about CSL. We want CSL to reflect the world around usAs a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL!

The OpportunityYou will be an Investigator I - BLP innovation where you will develop new technologies for the purification of plasma proteins. Inspire creativity/innovation and development of novel technologies in all aspects of therapeutic protein purification. Identify new opportunities for collaborations with external partners, serve as co-author on research proposals and evaluate technologies as part of Joint Research Committees. Be a technical expert in developing purification processes, analytical methods, and technical information to develop new technologies. Be a study director for development and screening of novel technologies, designs and perform experiments in the laboratory. The Role: Lead structured brainstorming, creative sessions, and vetting of ideas submitted by the team.Be a technical resource/mentor for the group in their field of expertise, by tracking technological/scientific developments in their area of expertise and implementing new methods to apply the new developments for maximum internal gain.Maintain an appropriate level of documentation and communication through drafting and execution of protocols and reports to support new processes. Report results promptly to site/global management.Train junior scientists or new scientists.Responsible for technical management of interns and temporary scientists.Plan and participate in experiments for the development and optimization of new purification processes and/or analytical methods.Be a technical lead for projects ongoing at the Waltham PPD Innovation Center.Coordinate scientific and investigative studies through collaboration with internal customers, global R and D sites, academic research organizations, contract laboratories, thinking creatively, and providing technical justification for novel concepts and approaches.Perform fundamental literature and patent searches related to activities and developing alternative strategies.Collaborate with Patents and Licenses Department to identify freedom to operate capabilities and novelty of discoveries.This is a lab-based position, therefore there will be limited opportunities for remote work. Your Skills and Experience: Postgraduate degree (preferably MSc or Ph.D.) and/or experience in relevant discipline.Minimum of 3 years of relevant industry experience and/or equivalent experience in a relevant academic environment.Experience in project work and excellent reasoning skills Our BenefitsCSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals. Please take the time to review our benefits site to see what’s available to you as a CSL employee. About CSL BehringCSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring. We want CSL to reflect the world around usAs a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Behring!

As a member of the GL leadership team, the director, GL data strategy and team assess and communicate the impact of key clinical endpoints on a future label. You will influence by articulating how agency advice and precedence and the competitive landscape support or require modifications to the design to deliver desired label outcomes. The position then maps the future label to potential advertising and promotion opportunities and tracks impact of recommendations to successful product promotion. Additionally, this position may identify labeling claims that could result from a proposed protocol. Assessment must occur early in product development activities and before endorsement of the pivotal protocol. Keeping the end in mind, impact analysis should include: analysis of endpoints, inclusion criteria, exclusion criteria, major market and key secondary market regulatory precedence and standard of care, experience gathered from other internal programs and HA requests for information along with experience gathered from competitors. The output can inform GL Strategists, Regulatory (global and region), Commercial and Clinical stakeholders regarding the trade-offs between the proposed protocol design and impact on labeling prior to committing to a protocol design and/or early development labeling strategy. For key marketed products, the director, GL data strategy/team identifies potential ways to leverage existing data to improve product differentiation based on regulatory and business goals. Using established methodology and tools, the data strategy team has the potential to also support response generation for other GRA strategic questions as requested by GRAST/GRALT. This position provides leadership, coaching, innovation and technical expertise, a keen understanding of country-specific regulatory requirements and the ability to connect data with strategy to meet company objectives. Main Accountabilities and responsibilties: • Lead data strategy assessment team across all TAs and put in place an E2E product information strategy during entire lifecycle. • Assess the impact of key endpoints on label using competitive intelligence and data analysis, regulatory precedence and knowledge of study design, development and trial conduct. • Utilize findings to make recommendations which inform sound decisions when developing labeling and/or regulatory strategies. • Create a natural linkage to global ad promo. • Liaise with GRA Regions, commercial development and commercial ops to ensure appropriate regulatory review of core product material and local ad promo review process and system/tools. • Use creative problem-solving and facilitate communication to key stakeholders by clearly explaining the science/regulatory perspective. • Act as a resource across GRA to provide insight for challenging questions based on established and proven methodology. • Build technology solutions that power future analysis and provides support across GRA through use of tools and established methodology. Qualifications and Experience: • University degree (4 year degree) in Life Sciences or Data Analysis; advance degree preferred. • Minimum of 12 years of biotech/pharmaceutical industry experience or a combination of 5+year’s experience in regulatoyr and/or related data analysis or clinical development experience Our BenefitsWe encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL. About CSL BehringCSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring. We want CSL to reflect the world around usAs a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Behring!

The Opportunity Reporting to the Head Regulatory Affairs APAC In-Licensed Products, you will be part of the CSL Seqirus APAC In-Licensing Regulatory Affairs Team. You will be based at our new CSL Head Office in Melbourne. CSL Seqirus in-licenses vaccines, pharmaceutical products and devices from our partner companies to ensure a comprehensive range of products is available to meet the needs of our patients in Australia and New Zealand. Current therapeutic areas in our in-licensing business include neurology, ophthalmology, pain management, travel vaccines and allergy. Each year, the in-licensing business grows, as additional products are in-licensed. The future is exciting and full of potential. This role does not currently have direct reports. There may, however, be the opportunity for one direct report in the future. The Role Responsibilities: Manage a portfolio of products covering various therapeutic areasDevelop and execute regulatory strategies to achieve successful regulatory outcomes, in accordance with business goals, including development of innovative strategies as neededPlan, prepare and submit high quality applications in Australia/New Zealand including regulatory agency briefing documentation, Category 1/3 applications, responses to evaluation reports and agency questionsIdentify & prioritise any potential risks and associated business impact and develop & implement appropriate mitigation plansPrepare and maintain Product Information, Consumer Medicine Information and labelling materialsPerform due diligence of new in-licensing product opportunities and provide high quality regulatory assessments of these opportunitiesMentor and supervise less experienced team members in the registration of new products or major variations, as well as in the due diligence of new product opportunitiesEstablish and maintain excellent relationships and communication with all stakeholders, including Health Authorities, Licensors, Health Economics, Medical, Marketing, Business Development, QA, Pharmacovigilance and Supply ChainLead the In-Licensing team's contribution to consultation papers from agencies, industry bodies and internal departmentsLead continuous improvement activities and processes for the In-Licensing teamProvide input into monthly reports and ensure that regulatory information management and tracking systems are updated to maintain regulatory compliance. Qualifications, skills and experience: Tertiary qualification in a biological science, allied medical discipline or pharmacyExtensive regulatory experience with prescription medicines in Australia and New Zealand, including negotiations with TGA and MedsafeExtensive experience in the submission and registration of new chemical entities or major variations involving clinical dataExcellent working knowledge of therapeutic goods legislation and guidelines for Australia and New ZealandExcellent communication and interpersonal skills, with a business solution and customer focusExcellent negotiation skills, persuasive writing skills and problem-solving skills We look forward to receiving your application. Applications must address the selection criteria above and include a current CV and covering letter. Applications close October 4th, 2023 Employment screening, including criminal history, medical assessment, confirmation of experience and stated qualifications, Australian working rights and other relevant checks form part of the candidate suitability. Our BenefitsWe encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL. About CSLCSL is a leading global biotechnology company with a dynamic portfolio of life-saving medicines, including those that treat haemophilia and immune deficiencies, as well as vaccines to prevent influenza. Since our start in 1916, we have been driven by our promise to save lives through innovation. Learn more about CSL. We want CSL to reflect the world around usAs a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL!

責任: ・自部署の社員及び業務で関連する派遣社員や関連会社員等を管理する。 ・最新の国内外の社内規制及び、国内外の法律や規制を遵守する。 ・国内の規制が変更された場合は、グローバルPVシステムに追加すべき変更の実施に向けた戦略的方向性を提案する。国内外、社内外の複数のファンクションの調整を含む、ファンクションをまたいだアプローチが必要とされる場合もある。 ・ 国際規制、ガイドライン、および社内基準に基づき、PSMFなど規制で義務づけられた書類を確立およびその維持を徹底する。 ・社内外の監査の準備と実施をサポートする。 ・シグナル検出と管理プロセスを監督／主導する。 ・安全性データの均一かつタイムリーな分析を徹底する。 ・ファンクション領域内で、新しいプロセスの記述、または現在のプロセスの改善／最適化の重要な取組みを主導または貢献する。安全性科学のインプットが必要とされる際のプロセス最適化を行うファンクションすべてのチームの専門家として行動する。 ・安全性データと分析に関する、研究活動または市販後活動に貢献する。 ・ユーザーの事業領域専門家およびソリューションを実施する技術チームにとって有益かつ有意義な形で、ユーザー要件を収集、列挙、および文書化する。 ・データベースの変更、またはユーザー／レポーティング要件変更による影響を分析する。 ・複雑な分析結果でも一般の視聴者にわかりやすくするための、データ視覚化ツールを模索、分析および導入する。 望ましい応募資格: • ライフサイエンスの学士号あるいは相当の学歴、または科学、医学／保健科学、疫学の修士号（または海外の相当の学歴）；または、科学、医学／保健科学、疫学の学士号（または海外の相当の学歴）に加えて、当該業界の関連する役割で3年の実務経験 • 多国籍製薬業界における、リーダーシップの役割の経験を含む、５年以上のファーマコビジランスの経験 • リーダーシップの役割を５年以上経験 • 国別／国際的ファーマコビジランス規制およびPVプロセスの専門知識 • 現地の／国際的な関連するGxP規制、IT基準、およびプライバシー保護関連法など他の関連法令の知識 • 規制当局による査察に対応した経験 • 複雑なデータセットの管理の経験 • プロジェクト管理CAPAおよびSOP策定の経験 • GxPの経験 • 関連するソフトウェアアプリケーションを使った経験 Our BenefitsWe encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL. About CSL BehringCSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring. We want CSL to reflect the world around usAs a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Behring!

In order to strengthen our Commercial Affiliate in Sweden, we are currently hiring a Regulatory Affairs Manager - Nordics to be located in Danderyd. As a member of the CSL Behring Nordic Team, the Nordic Regulatory Affairs Manager is responsible for regulatory compliance, maintenance and expertise for all medicinal product registrations where CSL Behring is the local representative in the Nordic region. Main responsibilities and accountabilities: You are part of a strong experienced team in the Quality, Regulatory Affairs and Pharmacovigilance department, and with support from Global functionsYou are responsible to manage, design and execute regulatory strategies for product portfolio and Life Cycle Management Submissions.You will provide guidance and oversee regulatory activities in support of timely submissions to ensure there are no interruptions in supply.You will oversee and manage company’s labeling documentation, adapt and modify according to national requirements, negotiate with agencies in order to obtain harmonized prescribing information/common Nordic labeling material. Coordinator of regulatory activities with local regulatory contactors and translators.You are an affiliate member of the European Regulatory Affairs team and act as the Nordic regulatory stakeholder management expert.You will provide regulatory and quality guidance into local management, commercial business teams and therapeutical area teams (e.g. on launch activities, tender applications, HTA applications, significant product changes, end-to-end labeling, marketing material).You will act as deputy Local Quality Officer working with fulfilling EU Good Distribution Practice (GDP) requirements defined in current local laws, HSLF-FS 2021:95 and later versions, according to the LQO delegate and CSL Behring global quality policies and procedures.You will support the Regional Safety Officer, in accordance with current PV regulations and company guidelines and SOPs.You will act professional and efficient to serve customers (internal and external) with high-quality information in a timely manner. Has strong self-leader and time efficiency skills. Qualifications and Experience Required: University degree, preferably in pharmacy or natural sciencesMinimum 10 years of regulatory experience in pharmaceutical companies, familiar with the regulatory environment in all Nordic countries.Preferred: Minimum of 5 years of experience as RP/QP working with fulfilling EU Good Distribution Practice (GDP) requirements.Experience working as project leader in cross functional teams driving implementation of new processes and new product registrations.Preferred: Experience with Medical Device and EU Medical Device Regulation. Reporting relations: Role that this position reports to: Head of Regulatory Affairs, Quality and Pharmacovigilance #LI-Hybrid #LI-MW1 Our BenefitsWe encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL. About CSL BehringCSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring. We want CSL to reflect the world around usAs a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Behring!

Position Purpose: The Clinical Compliance Operations (CCO) Manager is a position within Clinical Development Operations, R&D Japan responsible for supporting the Clinical Research & Development, Clinical Operations Tokyo and Project Management to provide therapeutically aligned compliance support to study teams focusing on adherence to procedural / regulatory requirements and Corrective and Preventive Action (CAPA) coordination to ensure inspection readiness. Reporting Relationships: This position reports to the Senior CCO Manager and will have global responsibilities in the following location: Tokyo Main Responsibilities and Accountabilities: 1) Provide compliance support, including quality and compliance advice / consultation, to the study programs conducted in Japan to ensure adherence with procedural / regulatory requirements and driving inspection readiness. 2) Manage Inspection Preparation activities for PMDA regulatory inspections and collaborate with Clinical Quality Assurance (CQA) to prepare internal staff. Support CQA during the regulatory inspection process to provide expertise regarding the Clinical Development quality management system. 3) Facilitate discussion on Risk-based Quality Management (RBQM) strategy and implement an effective Quality Risk Management Plan at the study level. 4) Support individual CAPAs, as appropriate, to ensure issues / deviations are thoroughly evaluated (including a risk assessment, root cause analysis and effectiveness measures) and identified actions are addressed in a timely manner. 5) Support the Senior CCO Manager in reporting metrics, identifying trends, and evaluating the effectiveness of completed CAPAs to drive continuous improvement. 6) Support the development of procedural documents (SOPs) to ensure regulatory compliance and consistency across Clinical Operations activities. 7) Manage SOP Training Completeness in Japanese Clinical Development according to the Japan SOP training matrix. 8) Support the Compensation Payment process to ensure Japanese regulatory compliance and subject’s welfare. 9) Provide GCP training to Japan clinical personnel as appropriate with support from Global CCO. Position Qualifications and Experience Requirements: Education Degree (BSc / MSc / Diploma) in scientific/medical/pharmaceutical discipline is essential, preferably combined with relevant clinical trial experience and / or relevant GCP auditing experience. Experience Extensive understanding of the clinical research and drug development life cycle.5+ years of professional work experience in a Clinical Development / GCP auditing.Experience in PMDA inspection preparation and management is desirable.Experience in a management role is desirable.Thorough knowledge of ICH GCP, Japan Pharmaceutical Affairs Law and GCP, FDA GCP Regulations and EU clinical trials directives. Competencies Experience of working in a global pharmaceutical environmentExperience of working in a Quality or Compliance related and / or Process Management related environment / roleStrategic development and analytical skillsExperience in managing processes with a continuous improvement approachStrong leadership and communication skills with special emphasis on collaboration, influencing and negotiation skillsDemonstrated ability to navigate and negotiate competing priorities in a challenging environmentAbility to think strategically and to quickly analyze complex circumstances and problems, and to drive appropriate decisions and actionsAbility to work and collaborate at all levels within an organizationExcellent communication and training skills, including English language skills desiredExcellent organizational and time management skillsAttention to detailAbility to work independently and as a team memberPlanning & co-ordination skillsDiplomacy skills Our BenefitsWe encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL. About CSL BehringCSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring. We want CSL to reflect the world around usAs a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Behring!

The Associate Director, Stability Strategy Lead will have the key responsibility of managing the stability and outsourcing strategy for the Global Drug Product (GDP) group in Plasma Product Development (PPD). The role will have oversight on both internal and external stability programs relating to development of CSL Behring’s plasma protein therapies. Managing a small team, the role will also be responsible for the deliverables relating to the GSP, GMP and in-use stability programs. The role will continually assess internal processes and performance of external partners to drive efficiencies in the delivery of outsourced work packages. The role will ensure establishment of a strong knowledge of operational and regulatory compliance involved in stability trial execution. The role will oversee the outsourcing strategy of the GDP team and partner with other internal functions and Contract Research Organisations to execute work packages. Role and responsibilities:Provision of technical leadership and project management for Stability trial programs relating to GDP projectsBrings a strong knowledge base of global outsourcing options and monitors the Drug Product landscape for continuous assessment of available opportunities.Maintains a transparent and clear understanding of the PPD timelines, product portfolio and forward-looking mindset. Develops tools for the GDP team to effectively manage project deliverables accounting for the dynamic needs of R&D and complex of the delivery network.Provides strong leadership and drive to define the stability and outsourcing strategy for the GDP team with regular reviews and targets. Ensures strategy aligns with 2030 PPD vision.Develops a business case including budget for assessment of outsourcing options for stability programs.Develop, implement and monitor key performance metrics to facilitate continuous improvement of management of stability process.Manages the organization of outsourced projects and implement processes together with the GDP SMEs, TT, CMC, BAS, Quality, and contract development.Drives endorsement and decision making for outsourcing needs.Manage representation for project execution teams relating to stability trial deliverables.Ensures transparency and timely access to stability data, ensures data integrity is in alignment with digital strategy.Oversight of QbD expectations and activities relating to stability studiesProvide guidance and input for stability sections of regulatory dossiers (CTA / IND / IMPD / BLA)Ensure high safety standards within the areas of responsibility are considered and adhered to as governed by local, state and federal regulations, laws and policies as well as CSL’s policies and directives. Educational background and past experiences Ph.D. in Protein Biochemistry, Pharmaceutical Science or related discipline with relevant industry experience or M.Sc.Track records in drug product development and management relating to stability trials for pharmaceutical products.Solid understanding of wider Drug Product development and regulatory requirementsThorough understanding of GMP and associated quality and validation systemsStrong skills in data analysis, trending, reporting/presentation, and problem-solving skillsDemonstrated ability in managing and / or contributing to highly effective teams.Experience in working in cross-functional, multicultural, and international teams.Experience in project work and analytical skills.Excellent oral communication and written skills.Excellent communication skills in English language. Our BenefitsWe encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL. About CSL BehringCSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring. We want CSL to reflect the world around usAs a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Behring!

Responsibilities: Responsible for leading all employee and external communications efforts for CSL Plasma, including internal, external and digital communications and thought leadership. Serves as primary news media spokesperson on behalf of CSL Plasma.Partners with CSL Plasma senior leaders to understand their priorities and develops and executes strategic, compelling and differentiated communications and brand programs that deliver on CSL Plasma and corporate objectivesOversees formulation and implementation of compelling communications and brand initiatives and engagement platforms that extend industry market leadership, support business/growth, respond/neutralize competitive challenges and guide issues and crisis managementEnsures one, coordinated external and employee communications strategy and execution plan – aligned with CSL Plasma priorities. The leader will be responsible for ensuring all CSL Plasma external and employee communications are coordinated and resources are leveraged across business locations Qualifications: Bachelor’s degree or equivalent in Marketing, Communications, Public Relations, Journalism or closely related field; MBA or Master in Communications a plus10+ years of progressive experience in private and/or public sector communications including external and employee communications is requiredDemonstrated experience in working with senior leadership, leading people and influencing stakeholders in matrixed global organization is highly desirableProven capabilities to be a strategist who can also provide tactical executionExperience in Pharma/Biotech or similarly regulated environment is desirable Our BenefitsCSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals. Please take the time to review our benefits site to see what’s available to you as a CSL employee. About CSL BehringCSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring. We want CSL to reflect the world around usAs a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Behring!

The role has lead responsibility for driving early innovation in North America via identifying, evaluating, and facilitating the integration of new products and technology opportunities into the Global Research portfolio; and leading the expansion of the strategic North American Research collaborative relationships to help deliver on Therapeutic Area (TA) and R&D strategy. Responsibilities:Lead the development and evolution of CSL’s Research External Innovation strategy in North America.Lead the proactive identification of North American discovery and pre-clinical innovation opportunities to support CSL’s Therapeutic Area strategy and Global Research External Innovation strategy in North America.Lead the management, growth and establishment of key, strategic collaboration and partnership opportunities with academic institutions, early-stage biotech companies and VCs in North America to drive Research Innovation and help deliver on the Global Research External Innovation strategy.Lead the expansion of CSL’s early research funding and collaboration initiatives in North America.Responsibility as the global Research External Innovation Lead for a designated Therapeutic Area(s), leading proactive identification and evaluation of all external Research opportunities relating to that Therapeutic Area(s) and membership of Research Therapeutic Area Leadership Team(s).Lead Research evaluations and due diligence assessments of new products, technology, and partnership opportunities.Work closely with CSL’s Strategy and Business Development and Global Licensing teams to facilitate agreement execution for innovation opportunities that pass Research Due Diligence.Manage Research External Innovation North America budget. Qualifications:PhD in relevant life sciences discipline requiredBusiness development/tech transfer experience in academia or industry requiredMinimum 10 years experience in life sciences sectorProven track record of driving new science and technology products/ platforms into pipeline projectsPostdoctoral experience in the field of either Immunology, Hematology, Respiratory, Cardiovascular & Metabolic Disease, or Nephrology & Transplant preferredDemonstrated proficiency at leading complex multi-faceted projects and managing cross-functional and cross-cultural teams. Our BenefitsWe encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL. About CSLCSL is a leading global biotechnology company with a dynamic portfolio of life-saving medicines, including those that treat haemophilia and immune deficiencies, as well as vaccines to prevent influenza. Since our start in 1916, we have been driven by our promise to save lives through innovation. Learn more about CSL. We want CSL to reflect the world around usAs a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL!

Responsibilities: Responsible for planning and implementing process improvement initiatives in support of CSL and industry best practicesEstablishes operational strategies and training for continuous process and quality improvementsResponsible to ensure the development of line extensions and new drug product development with third party companies as well as production of clinical trial samples according guidelinesLeads operational excellence initiatives for assigned region/site(s)Generates and analyzes trend reports on production processes and tracks effectiveness of changesSubject Matter Expert in drug product formulation development and packagingManagement of drug product development with internal resources and by CDMO collaborationsDevelopment of drug product formulations following Quality by Design principlesManufacturing of clinical trial supplies in compliance to cGMPWriting and support for regulatory dossiersRepresentative for Drug Product Development in crossfunctional project teamsSupports cross functional teams to ensure projects are rolled out and delivered according to milestones, budget and other relevant factorsCoordinates site wide project activities with other sites/functions in global CSL networkCoaches on use of re-engineering techniques to improve process performance Qualifications: Bachelor or Master degree in pharmacy or relevant discipline7+ years' experience in process management including team building experienceExperience working within the pharmaceutical industry with a background in late-stage development and/or production for sterile and non-sterile dosage forms, production and quality assuranceDemonstrated success in project management and continuous improvement processesKnowledge of Good Manufacturing Practices (cGMPs)Six-sigma certification/training We are looking forward to receiving your online application. Applications must include a motivation letter and CV, as well as letters of references and copies of relevant transcripts and/or diplomas in the original language. Please include all these in one document together with the CV. CSL Vifor is committed to provide equal employment opportunity for all. About CSL ViforCSL Vifor aims to become the global leader in iron deficiency and nephrology. The company is a partner of choice for pharmaceuticals and innovative patient-focused solutions across iron, dialysis, nephrology and rare conditions. CSL Vifor strives to help patients around the world with severe, chronic and rare diseases lead better, healthier lives. It specializes in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision patient care. For more information, please visit viforpharma.com We want CSL to reflect the world around usAs a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Vifor!

The Opportunity CSL Behring Australia is undergoing extensive change as we expand and grow. In addition to contributing to Australia’s export economy, CSL has invested and continues to invest in substantial new infrastructure that will support CSL’s global strategy and provide the network with crucial supply of product sourced from our Melbourne facility. Due to two internal promotions we are seeking two Operational Excellence Managers to support our growing Broadmeadows site. These full time permanent roles will have the opportunity to partner with key CSL Behring manufacturing and Quality Control departments to roll out and implement our overarching CSL Operating System founded on Lean 6 Sigma concepts. The Role Reporting to CSL Behring’s Operational Excellence Director Influence, coach and embed our Manufacturing Value Stream and Quality Control teams and their leaders on our CSL Operating SystemFacilitate workshops and deliver training for consistent deploymentConsistently driving process and metric measurement standardization and excellenceDrive efficiency gains by identifying and executing key projects aligned with the company strategic goalsDeliver year on year continuous improvement outcomes that solidify business relationships and deliver financial benefits for CSLSupport lifecycle management and project execution To be successful in this role you will have: Degree qualified in Manufacturing, Engineering/Science, HR, Business or allied areasProven experience in Project Management and adult learning5+ years demonstrated experience in one or more of the following areas; Operational Excellence; Project Management; Continuous Improvement and/or Learning and DevelopmentKnowledge of Lean or 6 Sigma concepts, change managementAn ability to communicate effectively and influence stakeholders from all levels of seniority Apply now to join Australia’s largest pharmaceutical site that is undergoing significant investment and change! Please submit your application in the one document. Applications close 24th November 2023. Our BenefitsWe encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL. About CSL BehringCSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring. We want CSL to reflect the world around usAs a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Behring!

The Opportunity The AMQ reports directly to the Associate Director, Operations & Quality. The RoleEnsure the center is "inspection ready" by managing adherence to Standard Operating Procedures (SOPs), compliance policies and the quality system.Manage the Quality Control program, calibrations management, monitor of compliance to defined processes e.g. sampling, competency checks, trending and analysis of KPIs, cause and failure mode impact assessment and change management.Recruit, hire, conduct performance reviews, lead investigations and deviations, enact corrective actions, and termination.Comply with all Health Safety and Environmental (HSE) and Occupational Safety and Health Administration (OSHA), federal, state and local regulatory, company policies/procedures.Follow all HR policies/practices through fair treatment of all employees.Monitor CAPA's and effectiveness checks to ensure issues are resolved.Overnight travel required up to 10% of the time.Experience 1 year supervisory, leadership experience responsible for overseeing the activities of others1year Quality experience (CSA/CSAb) requiredEducation Bachelor's Degree preferred OR equivalent combination of education and professional work experience requiredWorking Conditions Exposure to hazardous chemicals, extreme temperatures and to bloodborne pathogens.Required to wear Personal Protective Equipment while performing tasks or in certain areas Our BenefitsCSL offers the following benefits for this full-time position: Options for health care benefits, including choices of plans for medical, dental, and vision, prescription drug coverage; Company-provided basic life insurance and Short- and Long-Term Disability; the option to participate in CSL’s 401(k) Savings Program; Paid Time Off (PTO) for use in connection with vacations, illness, and other personal business; and paid observed holidays as designated by the Company. For more information on CSL Plasma benefits visit https://cslbenefits.com/cslp. About CSL PlasmaCSL Plasma is one of the world's largest collectors of human plasma. Our work helps to ensure that people with rare and serious diseases are able to live normal, healthy lives. We are committed to our work because lives depend on us. Learn more about CSL Plasma. We want CSL to reflect the world around usAs a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Plasma!