Careers

Associate Director, CMC Product Development & Commercialization

Full Time
74 E. Swedesford Rd, Suite 100, Malvern, PA, US
2 months ago | Requisiton ID:1024

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 status