Associate Director, CMC Product Development & Commercialization at Venatorx Pharmaceuticals, Inc in Malvern, Pennsylvania

Job Description:

Venatorx Pharmaceuticals, Inc

Full Time
Mgr & Dir - R&D/Ops
Malvern, PA, US

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.

Responsibilities:

• 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.

Qualifications:
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 statusPI131544928 Apply Now