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Associate Director – Director of Drug Substance
Structure Networks, Inc.Associate Director to Director role focusing on small molecule Technical Operations at Structure Therapeutics. Responsible for drug substance development and commercialization readiness in Shanghai.
About the role
Key responsibilities & impact- Responsible for Structure Therapeutics’ small molecule Technical Operations projects in terms of the development of drug substances
- Support late-stage drug substance activities in contract development and manufacturing organizations (CDMOs)
- Focus on late stage and commercialization readiness
- Manage all interactions with CRO’s or CDMOs to ensure delivery of high-quality results and reports in time to meet regulatory requirements, including GxPs
- Accountable for the delivery of proper documents for regulatory filings
- Develop robust and scalable synthetic routes suitable for commercialization
- Direct CRO teams to perform experiments to define process parameters intended to develop suitable processes for chemical manufacturing and commercialization
- Monitor the progress of projects and provide technical solutions to CRO and CDMOs
Requirements
What you’ll need- Ph. D or M.S’s degree in Organic chemistry, preferred in Organic Synthesis
- 10+ years of working experience in API development in biotech/pharma industry
- Being skilled in the application of GLP/cGMP is required
- Extensive drug substance process development background and hands-on experience with working knowledge of cGMP manufacturing
- Detail-oriented
- Ability to critically evaluate analytical data from a broad range of scientific disciplines
- Have both broad and in-depth knowledge as well as hands-on experience in modern organic chemistry techniques
- Outstanding problem-solving abilities
- Demonstrate knowledge of drug substance development, the ability to troubleshoot process development issues
- Project management skills are required
- Demonstrate a proven track record in working with and managing CROs and CDMOs for new synthesis design and execution in the lab and manufacturing
- Ability to operate effectively within an entrepreneurial and science-driven company environment; self-motivated, delivery-oriented, assertive, able to inspire others, driven and hands-on with unquestionable integrity and the highest ethical standards
- Excellent team player
- Language required: English and Chinese
Benefits
Comp & perks- Annual performance incentive bonus
- New hire equity
- Ongoing performance-based equity
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Organic chemistryOrganic synthesisAPI developmentGLPcGMPDrug substance process developmentAnalytical data evaluationModern organic chemistry techniquesProject managementSynthesis design
Soft Skills
Detail-orientedProblem-solvingCritical evaluationTeam playerSelf-motivatedDelivery-orientedAssertiveInspirational leadershipIntegrityEthical standards
Certifications
Ph.D.M.S.