Associate Director, CMC Product Development & Commercialization
The Associate Director, CMC – Product Development & Commercialization is responsible for parenteral and oral drug product manufacturing process development in collaboration with contract service providers. Responsibilities include process optimization, scale-up, validation, commercial production monitoring and troubleshooting. The Associate Director CMC – Product Development & Commercialization will partner with Venatorx subject matter experts and contract service providers to develop robust and economical manufacturing processes.
- Provide technical oversight of drug product manufacturing activities at contract service providers.
- Apply sound scientific principles and subject matter expertise to investigate, troubleshoot and resolve manufacturing issues at contract service providers.
- Identify opportunities to optimize the manufacturing processes, focusing on manufacturing quality, process robustness and efficiency.
- Contribute to the authoring of regulatory submissions related to manufacturing process definition and change control.
- Collaborate with project teams to meet project objectives, budget, and timelines.
Successful candidates will have the following qualifications:
- Ph.D. preferred, in Chemical Engineering, Biomedical Engineering or related Engineering or Scientific field with 5+ years of drug product development experience, or M.S. with 7+ years of relevant drug product development experience, or B.S. with 10+ years of relevant drug product development experience.
- 5+ years relevant industry experience in drug product development or technical operations, including process scale-up and technology transfer.
- Experience successfully partnering with CDMOs on manufacturing process development for late-stage product candidates and/or commercial products.
- Expertise in parenteral dosage form development & commercialization and aseptic process technology.
- Solid oral dosage form development and commercialization experience.
- Strong organizational and communication skills.
- Self-starter and a team player that will thrive in an entrepreneurial environment.
Ideal candidates will have the following additional qualifications:
- A graduate degree in in Chemical Engineering, Biomedical Engineering, Chemistry, or other relevant scientific discipline.
- Strong quantitative skills, including proficiency in mathematical modeling of chemical and/or pharmaceutical manufacturing processes.
- Lean Six Sigma certification.
Equal Employment Opportunity/M/F/disability/protected veteran status