Associate Director, Protein & ADC Drug Substance (Purification & Bioconjugation) | Biotechnologe (m/w/d)
BioNTech SE
Job Summary
This Associate Director role is pivotal in leading the external development and manufacturing of protein therapeutics and Antibody Drug Conjugates (ADCs). The successful candidate will serve as the Drug Substance (DS) Subject Matter Expert (SME), providing critical scientific and technical leadership across CMC development programs, with a specific focus on optimizing protein purification and ADC bioconjugation technologies. Day-to-day responsibilities include managing CDMO relationships, overseeing project documentation review (including regulatory filings like IND/BLA), managing CMC timelines and budgets, and defining the strategic execution plan for DS development. This position requires a Master’s or preferably a PhD in a relevant scientific field and at least five years of professional experience in a highly regulated, international environment, coupled with proven experience in early- and late-stage drug development strategy and execution. This role offers the opportunity to drive continuous improvement through the optimization of technologies, automation, and digitalization.
Required Skills
Education
Master’s degree or preferably PhD in Biotechnology, Bioprocess Engineering, Biochemistry, or a comparable field
Experience
- At least 5 years of relevant professional experience in an international and highly regulated environment
- Broad experience in protein (mAb) and ADC Drug Substance (DS) process development and manufacturing
- Proven experience in CMC development of early- and/or late-stage projects
- Experience in generation of regulatory documents and filings for biologicals and/or ADCs
Languages
Additional
- Not specified
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