2018-04-29

Drug Product Process Senior Engineer
Job Opportunity at Clinical Dynamix, Inc.

Posted on Apr 29

http://www.clinicaldynamix.com    888-558-2546

Location: Waltham, MA
Job Type: Full Time
Job ID: W4156446

Director, Medical Information
for this leading pharmaceutical company in New England
S Headquarters in Waltham, MA
Looking for Senior Engineer
for drug product unit operations- leadership 
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 Company 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
 Competitive Base, Bonus, Long Term Incentives and Relocation
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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