Principal Investigator, Process Chemistry
Incyte
7 hours ago
On-site
Wilmington, DE
Other
Job Summary (Primary Function)
- The Principal Investigator, Process Development conducts chemical process research and development.
Responsibilities (Key Responsibilities)
- Manage HTE Center equipment and ensure reliable performance; coordinate with equipment vendors/service providers to resolve issues and minimize downtime.
- Execute HTE experiments to identify optimal conditions; collaborate with Drug Discovery to prepare required quantities of drug candidates and accelerate discovery programs.
- Generate, curate, and deliver HTE datasets to support predictive AI/ML model development.
- Provide chemical process support for development projects in collaboration with other functions.
- Partner with internal/external QC and QA to ensure high-quality API batches are manufactured and delivered on time.
- Work with selected CROs to design machinery, equipment, and quality control instruments for API manufacturing.
- Review master batch production records and executed batch production records for drug substance manufacturing under cGMP.
- Provide technical support to CROs/CMOs to develop commercial manufacturing processes for drug substances.
- Write technology transfer documents, campaign summaries, and project progress reports.
- Provide input to medicinal chemistry on new syntheses and optimized chemical processes.
- Develop reliable, cost-effective chemical processes for late-stage drug candidates.
- Design scalable synthetic routes for drug substance manufacture.
- Provide internal scale-up and process optimization support for non-GMP early-stage drug substance needs.
Qualifications
- Ph.D. in Synthetic Organic Chemistry.
- 3+ years industry HTE group experience.
- Demonstrated problem-solving, planning/organization, verbal/written communication, and team collaboration.
- Ability to develop high-quality, cost-effective processes that improve medicine reach.
- In-depth knowledge of synthetic organic chemistry, chemical process development, and API manufacturing (including process design using plant equipment, reaction kinetics, hazard analysis, and physical/thermodynamic data).
- Minimum relevant pharmaceutical industrial experience in chemical process R&D and/or medicinal chemistry, or equivalent skills/experience.
- The Principal Investigator, Process Development conducts chemical process research and development.
Responsibilities (Key Responsibilities)
- Manage HTE Center equipment and ensure reliable performance; coordinate with equipment vendors/service providers to resolve issues and minimize downtime.
- Execute HTE experiments to identify optimal conditions; collaborate with Drug Discovery to prepare required quantities of drug candidates and accelerate discovery programs.
- Generate, curate, and deliver HTE datasets to support predictive AI/ML model development.
- Provide chemical process support for development projects in collaboration with other functions.
- Partner with internal/external QC and QA to ensure high-quality API batches are manufactured and delivered on time.
- Work with selected CROs to design machinery, equipment, and quality control instruments for API manufacturing.
- Review master batch production records and executed batch production records for drug substance manufacturing under cGMP.
- Provide technical support to CROs/CMOs to develop commercial manufacturing processes for drug substances.
- Write technology transfer documents, campaign summaries, and project progress reports.
- Provide input to medicinal chemistry on new syntheses and optimized chemical processes.
- Develop reliable, cost-effective chemical processes for late-stage drug candidates.
- Design scalable synthetic routes for drug substance manufacture.
- Provide internal scale-up and process optimization support for non-GMP early-stage drug substance needs.
Qualifications
- Ph.D. in Synthetic Organic Chemistry.
- 3+ years industry HTE group experience.
- Demonstrated problem-solving, planning/organization, verbal/written communication, and team collaboration.
- Ability to develop high-quality, cost-effective processes that improve medicine reach.
- In-depth knowledge of synthetic organic chemistry, chemical process development, and API manufacturing (including process design using plant equipment, reaction kinetics, hazard analysis, and physical/thermodynamic data).
- Minimum relevant pharmaceutical industrial experience in chemical process R&D and/or medicinal chemistry, or equivalent skills/experience.