Senior Engineer, Drug Product Process Development

Alkermes   •  

Waltham, MA

Industry: Pharmaceuticals & Biotech


11 - 15 years

Posted 170 days ago

This job is no longer available.

This position will provide technical leadership for small molecule drug product unit operations, scale-up and optimization in development from R&D to cGMP Phase 3 manufacture to process validation  Experience with continuous manufacturing, scale-up and PAT implementation is strongly desired.  The individual is expected to integrate QbD principles, guide experimental design with a focus on process understanding and robustness, interpret data, participate in cross-functional teams, write technical reports and mentor fellow engineers.  The candidate should have strong communication, a commitment to continuous learning, a strong sense of curiosity and be a good team player.  A solid background in chemical engineering is required.


Responsibilities include but are not limited to:

  • Collaborate within cross-functional teams, specifically with Formulation and Analytical Development to define and execute development strategies that enable successful launch of Alkermes products
  • Implement scale-up strategies for drug product unit operations with a focus on process understanding, identification of critical process parameters and process optimization
  • Apply particle engineering and process modeling in development activities.  Identify and deploy new technologies as needed.
  • Design manufacture processes that deliver drug product of desired attributes
  • Support technology transfer of drug product unit operations and production at CMO(s)
  • Integrate Quality Risk Management (QRM) and Quality by Design (QbD) principles into project activities in accordance with ICH Q9 & Q11
  • Write technical reports and deliver presentations to technical, CMC and broader project groups.
  • Author & review CMC sections of regulatory filing documents
  • Mentor fellow engineers


Minimum Education & Experience Requirements:

  • MS in Chemical Engineering with 10+ years of experience
  • PhD in Chemical Engineering with 3+ years of experience