Associate Director, Drug Substance Development Direct Hire MA

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Job ID: 15806 Direct Hire MA

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Global biopharmaceutical company here in the Woburn MA area is looking to add a Small Molecule Associate Director to their Process Development team!  Company is known for their innovative medicines to treat chronic CNS diseases and has commercial products! This position will support the development of novel active compounds within the company’s pipeline.  Specifically, this position will provide strategic leadership for drug substance unit operations, scale-up and optimization in development from R&D to cGMP Phase 3 manufacture to process validation.  Specific areas of focus include reaction engineering, crystallization and process modeling.  The individual is expected to integrate QbD principles, guide experimental design with a focus on process understanding & robustness, interpret data, participate in cross-functional teams, write technical reports and mentor fellow engineers.  The candidate should have strong communication & interpersonal skills, be able to multi-task and have a commitment to continuous learning.  A solid background in chemical engineering is required.  Responsibilities include but are not limited to: 

  • Collaborate within cross-functional teams, specifically with Chemical and Analytical Development to define and execute development strategies that enable successful launch of products.
  • Implement scale-up strategies for drug substance synthesis and crystallization unit operations with a focus on process understanding, identification of critical process parameter and process optimization.
  • Apply reaction engineering and process modeling in development activities.  Identify and deploy new technologies as needed.
  • Design crystallization processes that deliver solids of desired attributes
  • Support technology transfer of drug substance 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
Requirements:

  • MS in Chemical Engineering with 15+ years of experience OR PhD in Chemical Engineering with 10+ years of experience
  • 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
  • Experience in drug substance crystallization
  • Pharmaceutical cGMP manufacturing experience
  • Statistical design of experiment experience