Principal Investigator, Process Chemistry

Overview Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value. The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules.

Job Summary (Primary function) The Principal Investigator, Process Development conducts chemical process research and development. Essential Functions of the Job (Key responsibilities) Manage HTE Center equipment and ensure reliable performance in daily operations. Coordinate with equipment vendors and service providers to resolve equipment issues and minimize downtime. Execute HTE experiments to identify optimal conditions as requested by Process Development. Collaborate with Drug Discovery to prepare required quantities of drug candidates and accelerate discovery programs.

Generate, curate, and deliver HTE datasets to support development of predictive AI/ML models. Work with other functions to provide chemical process support for the development projects. Work closely with internal and external QC and QA functions to ensure each batch of the high-quality APIs is manufactured and delivered on time. Work with the selected Contract Research Organizations (CROs) to design machinery, equipment and quality control instruments for the selected API manufacturing process.

Review master batch production records and the executed batch production records for manufacturing drug substances under cGMP. Provide technical support to CROs/CMOs to develop the commercial manufacturing processes for producing drug substances. Write the technology transfer documents, campaign summaries, and project progress reports. Provide input to medicinal chemistry with regard to new syntheses and optimized chemical processes. Develop reliable and cost-effective chemical processes for late-stage drug candidates.

Design the scalable synthetic routes for manufacture of drug substances. Provide internal scale-up and process optimization support to meet non-GMP drug substance needs for the early stage drug candidates. Qualifications (Minimal acceptable level of education, work experience, and competency) Ph.

D. in Synthetic Organic Chemistry. 3+ years industry HTE group experience Demonstrated ability in problem-solving, planning and organization, effective verbal and written communication, and collaboration within team. Clear understanding of the importance of developing high-quality and cost-effective processes that will, ultimately, result in more medicines reaching a diverse range of patient. In-depth understanding of synthetic organic chemistry, chemical process development and API manufacturing to adopt at designing processes based on plant equipment, reaction kinetics, hazard analysis and physical and thermodynamic data.

Minimum of relevant pharmaceutical industrial experience involving chemical process research and development and/or medicinal chemistry, or equivalent skills and experience.

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required. Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.

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