Director, Process Engineering and Validation
Director, Process Engineering and Validation
STEMSourcing
United States
See who STEMSourcing has hired for this role
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.
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Seniority level
Director -
Employment type
Full-time -
Job function
Manufacturing -
Industries
Biotechnology Research
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