Director, Process Engineering and Validation

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.