Associate Director, Manufacturing

vor 2 Wochen

Nuernberg, Deutschland BioTalent Vollzeit

BioTalent are partnered with a specialist biologics start-up based in Munich, to support the hire of an Associate Director to support the management of external manufacturing and acting as an SME on production methodologies, whilst providing dynamic leadership to a growing division.

This role will offer you:

- The chance to take ownership of external manufacturing processes for a range of biologicals such as ADCs and mAbs, working in a collaborative environment whilst ensuring GMP and CMC compliance.

You will be responsible for:

- Leading the assessment, selection and management of external CMO partners, supervising the manufacturing process whilst establishing and building supplier relationships.
- Reviewing and approving manufacturing and CMC documentation such as master batch records, and establishing procedures for documentation execution moving forwards.
- Setting up manufacturing procedures, building the foundation of the division initially as an individual contributor, before building and leading the group.
- Collaborating with internal QA staff members for documentation compliance and establishing review processes, in addition to collaborating with Process Development divisions to provide expertise for late stage development, scale-up and GMP alignment activities.

You will bring the following:

- Over 5 years of industrial experience within a biologics drug substance manufacturing environment, with expertise in upstream and downstream manufacturing processes
- Experience managing production processes within a CMO/CDMO, or managing external manufacturing suppliers

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