Associate Director, Protein, ADC Drug Substance

Role Overview

• Provide project overarching drug substance support (mainly protein purification and ADC bioconjugation)
• Serve as a local interface for all clinical CMC project teams with Chinese collaboration partners, CDMOs, and vendors
• Support operational & troubleshooting activities on-site
• Support technical transfers to in-China and ex-China sites (focus clinical phase)
• Internal audits and Health Authority inspections
• Engage directly with local collaboration partners, CDMOs, vendors, etc. to support drug substance development and GMP manufacturing for protein and ADC projects
• Review project documentation, including development reports, risk analysis, qualification/validation reports, batch records and release documentation according to regulatory guideline.

Requirements

• Master’s degree in chemistry, Biopharmaceuticals, Biochemistry, Biology, or a comparable field with at least 5 years of relevant professional experience in an international and highly regulated environment
• Proven experience in mAb and ADC Drug Substance process technologies with preferably specific operational experience in mAb DSP or ADC bioconjugation
• Sound experience in CMC development of early
• and late-stage projects, including strategy definition and strategy execution, with a sound understanding of all stages of the drug development process
• Sound GMP knowledge and experience with regulatory filings for biologicals (IND/IMPD, BLA/MAA)
• Excellent project management skills, capable of working in cross-functional CMC teams and with external stakeholders
• Excellent communication and negotiation skills as well as ability to communicate complex technical matters in a clear and concise way to various stakeholders.

Benefits

• 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 is determined by the specific role, location of employment and also the selected candidate’s qualifications and experience.
• Note: The availability, eligibility and design of the listed benefits may vary depending on the location.
• The final requirements for the individual use of our benefits are based on the company's internal policies and applicable law.