Offer summary
Qualifications:
Ph.D. in Chemistry or related area with 5 years' experience, Proven track record in QC lead role, familiarity with regulatory guidelines and quality systems.
Key responsabilities:
- Develop control strategy for peptides, oligos, and conjugates; Manage testing activities at CMOs/CTLs
- Coordinate reference standard qualification, stability design, lab investigations
- Lead submission of regulatory reports, review validation protocols and reports
- Mentor junior scientists, collaborate with external partners, handle third-party contracts
- Implement work plans, oversee stability programs, conduct audits if necessary