Analytical Methods Development (m/f/d)
France
Permanent
Negotiable
Research And Development
PR/552205_1752133018
Analytical Methods Development (m/f/d)
Analytical Methods Development (France/Germany)
Support analytical method development, validation, and transfer for biologics (antibodies, fusion proteins). Ensure data integrity, regulatory compliance, and product quality through release/stability testing and statistical analysis. Act as technical reviewer and author for quality documentation. Collaborate with CDMOs and internal teams, contribute to regulatory submissions, and represent the company externally.
Key Responsibilities
- Develop and validate analytical methods
- Characterize products, standards, and impurities
- Review lab data, SOPs, protocols, and reports
- Author CoAs, technical reports, and regulatory documents
- Monitor reference standards and stability programs
- Lead CDMO interactions and internal collaborations
- Support BLA/MAA documentation and regulatory responses
- Contribute to budget forecasts and development plans
Qualifications
- Advanced degree in chemistry, biochemistry, life sciences, or engineering
- 7+ years in method validation and analytical transfers
- 2+ years in cGMP QC in pharma/biotech
- Hands-on experience with bioanalytical techniques (e.g., HPLC, CE, ELISA)
- Strong knowledge of GxP, ICH, and regulatory standards
- Proficient in statistical tools (JMP/Minitab), Microsoft Office
- Project management and CDMO collaboration experience
- Fluent in English