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Associate Director, External QC Network
BioNTech SEAssociate Director overseeing External QC Network at BioNTech, managing QC at CMOs predominantly located in China. Requires strong experience in pharmaceutical QC and CMC development.
About the role
Key responsibilities & impact- Represent External QC Network at CMOs (predominantly located in China) ensuring QC and GMP requirements of BioNTech are considered
- Represent external/global QC in multidisciplinary project team and define QC project strategy in related projects
- Oversees the stability program of late development projects.
- Ensures that stability programs are implemented and adhered to and that results are reported and evaluated.
- Oversee QC activities at CDMOs and ensure delivery of QC-associated work packages (data evaluation, deviation/OOS-investigations, CoA generation and release) in time and quality
- Act as link between global External QC Network team and Chinese CMOs
- Participate in generation and approval of QC-related GMP-documentation
- Management of full QC-value chain for relevant projects/products
Requirements
What you’ll need- University degree in a scientific/life-science-related field (PhD)
- Minimum of 5-7 years of experience in responsible positions in QC (ideally including analytical development) within the pharmaceutical industry
- Profound experience in CMC development, including commercialization and stewardship of commercial products
- Experienced in interaction with Chinese, European and US pharmaceutical companies
- Experience in managing CDMO networks globally
- Strong analytical background with antibodies and ADCs
- Analytical background in chemical synthesis (Linker payload synthesis) is a plus
- Previous experience in a function leadership role
- Strong communication as well as (self-)organizing skills
- Fluent English (both oral and written)
Benefits
Comp & perks- competitive remuneration packages
- variety of benefits in support of our diverse employee base
ATS Keywords
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Hard Skills & Tools
Quality ControlAnalytical DevelopmentCMC DevelopmentData EvaluationDeviation InvestigationCoA GenerationLinker Payload SynthesisStability Program ManagementProject Strategy DefinitionGMP Documentation
Soft Skills
Strong Communication SkillsSelf-Organizing Skills
Certifications
PhD in Scientific/Life-Science Field