External QC Network Lead (CMOs)

About the Role

Join BioNTech as the External QC Network Lead, representing the QC function at CMOs (predominantly located in China) and ensuring QC and GMP requirements are integrated into BioNTech projects. You will serve as a link between the global External QC Network and Chinese CMOs, define QC project strategy within multidisciplinary teams, and oversee QC activities across late development programs.

What You'll Do

• Represent External QC Network at CMOs (predominantly in China), ensuring QC and GMP requirements of BioNTech are considered.
• Represent external/global QC in multidisciplinary project teams and define QC project strategy in related projects.
• Oversee the stability program of late development projects, ensuring programs are implemented, results 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 a link between the global External QC Network team and Chinese CMOs.
• Participate in generation and approval of QC-related GMP documentation.
• Manage the full QC-value chain for relevant projects/products.

What We're Looking For

• University degree in a scientific/life-science-related field; PhD strongly preferred.
• Minimum of 5-7 years of experience in responsible QC positions within the pharmaceutical industry (ideally including analytical development).
• Profound experience in CMC development, including commercialization and stewardship of commercial products.
• Experience interacting 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 and (self-)organization skills.
• Fluent English (oral and written).

Nice to Have

• Analytical background in chemical synthesis (linker payload synthesis) is a plus.

Compensation & Benefits

• Note: 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 are variable and dependent on company and individual performance). Compensation for the role will depend on several factors, including responsibilities of the job, education, experience, knowledge, skills, and abilities. Compensation at other locations may vary significantly.
• BioNTech is committed to the wellbeing of our team members and offers a variety of benefits in support of our diverse employee base. We offer competitive remuneration packages which are determined by the specific role, location of employment and the candidate’s qualifications and experience.
• Note: Availability, eligibility and design of listed benefits may vary by location, and final requirements for benefit use are based on internal policies and applicable law.