Associate Director, Commercial Manufacturing

Job Description
We are seeking a Chemical Engineer experienced in small molecule process development and commercial manufacturing to join our Chemical Development and Manufacturing team to support commercial manufacturing of Ripretinib (QINLOCK) and Vimseltinib and may have input to development and clinical supply of important new medicines working 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, PhD in Chemical Engineering, or related field with experience in manufacturing GMP drug substance 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 intermediate 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, and particle-sizing technologies. 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:
Provide virtual oversight to contract manufacturers across a diverse range of unit operations to support qualification, supply, and cGMP manufacture.
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.
Maintain in-process equipment parameter tracking and trending analyses.
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.