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Associate Director, External QC Network – China
BioNTech SEAssociate Director for External QC Network at BioNTech representing QC at CMOs in China. Overseeing stability programs and managing QC value chain for projects/products.
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 which is determined by the specific role, location of employment and also the selected candidate’s qualifications and experience.
- If the position is filled in the US, the Expected Pay Range is XXX,XXX/year to XXX,XXX/year + benefits, annual bonus & equity (bonus and equity is variable and dependent on company and individual performance).
- BioNTech is committed to the wellbeing of our team members and offers a variety of benefits in support of our diverse employee base.
ATS Keywords
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Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
QCGMPCMC developmentanalytical developmentdata evaluationdeviation investigationsOOS investigationsCoA generationchemical synthesisLinker payload synthesis
Soft Skills
communicationself-organizationleadership
Certifications
PhD