about the company.
A Leading Biotech
about the team.
Driven by a world-class R&D team with proven track records in biotherapeutics platform innovation.
about the job.
- Lead end-to-end CMC strategy and execution for biologics programs from early discovery through clinical development and commercial readiness.
- Oversee external CDMO management and global regulatory strategy, ensuring phase-appropriate drug substance and drug product manufacturing compliance.
- Direct cross-functional tech transfer, process development, and analytical characterization teams to drive aggressive pipeline milestones.
skills and experience required.
- Ph.D. in Chemical Engineering, Biochemistry, Biotechnology, or a related discipline with 12+ years of biopharmaceutical CMC leadership experience.
- Demonstrated track record of successful IND/IMPD filings and late-stage tech transfers for novel antibody or complex protein formats.
- Strategic mindset with deep expertise in CDMO oversight, regulatory submission guidelines (FDA/EMA/NMPA), and cross-functional leadership.