Senior Research Scientist
On-siteShanghai, Shanghai, China
Job Summary
Lead the development of robust, safe, and cost-efficient commercial routes for synthetic molecules, including peptides, by resolving chemical process challenges at CDMO partners during scale-up, tech transfer, and registration campaigns. Secure intellectual property by identifying patentable innovations and supporting filings while evaluating and selecting CDMOs with a focus on Asia/Pacific partners. Provide technical oversight of CDMO partners, managing work packages and budget forecasting to ensure project milestone delivery through on-site visits that verify quality standards, process safety, and timelines. Collaborate with internal analytical and formulation teams to support global regulatory submissions and ensure cGMP compliance. Act as a point of contact for global project teams and provide expert API guidance for business development and licensing initiatives. Report to the Senior Director of Global API Development in Indianapolis, USA.
Required Qualifications
- PhD in organic chemistry or chemical engineering, or related scientific fields
- 5+ years industry experience
- M.S. degree
- 10+ years industry experience
- Strong expertise in route selection
- Strong expertise in process development/optimization
- Strong expertise in process tech transfer
- Proven experience working with CDMOs
- Solid understanding of cGMP production
- Solid understanding of regulatory requirements
- Fluent in English
- Fluent in Chinese (spoken and written)
Desired Qualifications
- Advanced education or working experience in Chemical Engineering
- Education in peptide synthesis
- Experience working with synthetic peptide drug development
- Expertise in solid state property characterization
- Expertise in data interpretation
- Experience with statistical tools and principles (e.g. design of experiments)
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