COMPLETE Associate Director, Stability Strategy Lead in the Plasma Product Development Team - EMEA, CH, Kanton Bern, Bern, 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 projects
• Brings 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 studies
• Provide 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 requirements
• Thorough understanding of GMP and associated quality and validation systems
• Strong skills in data analysis, trending, reporting/presentation, and problem-solving skills
• Demonstrated 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.

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About CSL Behring

CSL 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.

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