COMPLETE Senior Manager Drug Product Development - EMEA, CH, Kanton St. Gallen, St. Gallen, CSL Vifor

Responsibilities:

• Responsible for planning and implementing process improvement initiatives in support of CSL and industry best practices
• Establishes operational strategies and training  for continuous process and quality improvements
• Responsible 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 guidelines
• Leads operational excellence initiatives for assigned region/site(s)
• Generates and analyzes trend reports on production processes and tracks effectiveness of changes
• Subject Matter Expert in drug product formulation development and packaging
• Management of drug product development with internal resources and by CDMO collaborations
• Development of drug product formulations following Quality by Design principles
• Manufacturing of clinical trial supplies in compliance to cGMP
• Writing and support for regulatory dossiers
• Representative for Drug Product Development in crossfunctional project teams
• Supports cross functional teams to ensure projects are rolled out and delivered according to milestones, budget and other relevant factors
• Coordinates site wide project activities with other sites/functions in global CSL network
• Coaches on use of re-engineering techniques to improve process performance

Qualifications:

• Bachelor or Master degree in pharmacy or relevant discipline
• 7+ years' experience in process management including team building experience
• Experience 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 assurance
• Demonstrated success in project management and continuous improvement processes
• Knowledge 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 Vifor

CSL 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 us

As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.

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