Senior Engineer, Process Development ( Drug Product / Continuous Manufacturing )

Alkermes   •  

Waltham, MA

Industry: Biotech/Pharma


11 - 15 years

Posted 392 days ago

This position will provide technical leadership for 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 and PAT implementation is a plus.  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 chemicalengineering 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


Knowledge/Skills Needed:

  • Excellent written and oral communication
  • Experience in introducing, implementing and/or executing new chemical processes in pilot, commercial plants and/or contract manufacturing facilities
  • Proven ability to apply scientific principles to design, execute and interpret experiments
  • Pharmaceutical cGMP manufacturing experience
  • Statistical design of experiment experience
  • Team player with good interpersonal skills


Desired but not required:           

  • Continuous process development and manufacturing
  • PAT experience & chemometrics (e.g. NIR, Raman)
  • Experience in working with DEA controlled substances
  • Quality by Design experience


Personal Attributes Needed:

  • Motivated self-starter
  • Positive, adaptable, can-do attitude
  • Ability to work independently
  • Ability to travel and work flexible hours as required
  • Functional ability to work in a pilot plant and commercial facility


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