The role of Scientist in Process Chemistry will be responsible for the development of robust, well-understood processes and the timely manufacturing of cGMP materials using outside vendors. This will involve the identification and documentation of key process parameters, relevant process controls, the origin of impurities, and appropriate strategies for control of product quality. The role will further provide chemical development subject matter expertise during quality events and regulatory submissions.
- Work with contract R&D partners to develop robust, phase-appropriate processes for production of small molecule raw materials, intermediates and APIs
- Design experiments to define reaction, isolation and purification processes, identify design space, and confirm robust process performance under cGMP conditions
- Interpret raw data, organize results, generate/review reports, and communicate findings to project teams and management
- Support vendor management activities, including vendor selection, technology transfer, and cGMP manufacturing campaigns
- Represent Process Chemistry in internal cross-functional CMC teams
- Collaborate with Formulation Development and Analytical Development to define and execute development strategies that enable phase appropriate deliverables
- Effectively summarize key information such as program progress, timeline updates, and risk/opportunity assessments for CMC teams and management
- Conduct scenario planning to proactively provide analysis and recommendations on alternative development plans, along with associated assumptions and risks
- Investigate, identify root causes, and approve CAPAs for manufacturing deviations
- Contribute to process risk assessments, process validations, and other commercialization -related API activities from clinical development through product approval and beyond.
- Assist in the evaluation of CMC documents during due diligence exercises and the review of source documents during regulatory filing preparations