Senior Process Engineer
The Senior Process Engineer, Pharmaceutical Process Development is responsible for drug product manufacturing process development in collaboration with contract manufacturing organizations (CMOs). Responsibilities include process optimization, scale-up, validation, commercial production monitoring and troubleshooting. The Senior Process Engineer will partner with Venatorx subject matter experts 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. in Chemical Engineering, Biomedical Engineering, Materials Engineering, or other related engineering field with 3+ years of relevant drug product development experience, or M.S. with 5+ years of relevant drug product development experience, or B.S. with 7+ years of relevant drug product development experience.
- At least three years of relevant industry experience in drug product development or technical operations, including process scale-up and technology transfer.
- Experience successfully partnering with CMOs on manufacturing process development for late-stage product candidates and/or commercial products.
- Expertise in solid oral dosage form manufacturing process development, technology transfer, and commercialization.
- Proven experience in aseptic manufacturing process technology, such as parenteral dosage form development & commercialization.
- Strong organizational and communication skills.
- Self-starter and a team player that will thrive in an entrepreneurial environment.
Equal Employment Opportunity/M/F/disability/protected veteran status