Our client, an Oncology focused company in late-stage Clinical Development, is looking to add an experienced and talented Process Engineer to their team. The ideal candidate will have a values-driven work style and demonstrated ability for excellence in drug discovery and development and good knowledge of late-stage development, process registration, validation, and launch requirements.
Job functions include:
Responsible for leading the engineering aspects and oversight of process development, and process validation elements for successful scale-up of chemical manufacturing processes and drug product manufacturing processes.
Establish criteria to ensure processes are scalable and robust for drug substance manufacture (including the related raw materials and intermediates) and the routes and strategies are suitable for commercialization.
Establish, review, and support process validation DOE strategies and evaluations to verify drug product processes are scalable and robust for validation and commercial launch.
Participate in the design of synthetic processes to target molecules (including RSMs and intermediates) to develop cost-efficient, scalable and robust drug substance manufacturing processes.
Provide strategic planning as well as technical support and management for contract manufacturing organization (CDMO’s) to prepare manufacturing batches.
Review and approve associated development reports and other development-related documents.
Guide external third parties through technology transfer, process development, optimization, qualification, and validation of the activities related to DS and DP manufacturing operations. Be on-site, as necessary.
Collaborate with other functions to assure compliance with applicable GMP and global regulatory requirements.
Author and review of CMC sections for regulatory filings (INDs, IMPDs, NDAs, MAAs).
Provide technical strategic support and documentation for answering questions during regulatory submission reviews.
Job Requirements:
BS/MS, or Ph.D. in Chemical Engineering
A minimum of 10+ years’ industry experience in process development and validation of API and/or DP processes as well as CDMO management
Strong knowledge of cGMP requirements relating to drug substance and drug products
Strong knowledge of DS/DP process development, manufacture and validation.
Seniority level
Director
Employment type
Full-time
Job function
Manufacturing
Industries
Biotechnology Research
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