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- Provide technical review of supplier batch records for development/tech transfer and related GMP documentation (e.g., raw material and product specifications, equipment specifications, validation protocols/reports).
- Maintain CQA, in-process, and release data tracking and trending analysis.
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- Provide 'person in plant' oversight to GMP related activities.
- Assist in execution of formalized process risk assessment activities (e.g. FMEA) to support process qualification and regulatory submissions.
- Help oversee CDMO development and qualification activities required to support and launch activities as well as advise on additional early phase program development.
- Support writing and review applicable sections of CMC regulatory filings.
- Author and review relevant Tech Ops SOPs in collaboration with QA.
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Director, Commercial Manufacturing - Waltham, MA, United States - Deciphera Pharmaceuticals
Description
Job Description
We are seeking a Chemical Engineer experienced in small molecule Drug Substance and Drug Product process development and commercial manufacturing to join our Pharmaceutical Development and Manufacturing team. This position will support commercial manufacturing of Ripretinib (QINLOCK) and Vimseltinib and may have input to development and clinical supply of important new medicines. This role will have the opportunity to work with committed and passionate colleagues in a collaborative and team-based culture and with our global CDMO partners.
The ideal candidate will have an BS, MS, or PhD in Chemical Engineering, or related field with experience in manufacturing GMP drug substance and drug product in a virtual environment. The candidate should also have a command of chemical synthesis and purification for small molecule drug substance (active pharmaceutical ingredient) and drug product unit operations.
Specific areas with which the candidate should be familiar with include, but are not limited to, crystallization engineering, batch processes, reaction scale-up, spray drying, blending, and tableting. The candidate should have hands-on experience with development and implementation of controls and processes needed to manufacture under GMP requirements. Familiarity with regulatory writing, quality management and oversight of CDMO activities, and review of batch records and technical reports and qualifications are also important. The successful candidate will be strong in both written and spoken communications, well-organized, and able to thrive in a fast-paced environment.
This position is anon-site position at our Waltham, MA office with up to 25% domestic and international travel required, and will report to the Senior Director, Pharmaceutical Engineering.
What You'll Do:
