Careers

Senior Process Engineer

Full Time
74 E. Swedesford Rd, Suite 100, Malvern, PA, US
1 month ago | Requisiton ID:1040

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.     

 

Responsibilities include:

  • 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. 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