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Principal Scientist, API Process Development and Manufacturing

Norwood, MA 02062

Posted: 04/15/2019 Employment Type: Direct Hire Job Category: Clinical: Scientific Job Number: 2308

The Principal Scientist, API Process Development and Manufacturing job responsibilities include:
  • Development of robust and cost effective API manufacturing processes using an outsourcing model.
  • Utilization of fundamental process chemistry principles to characterize and solve manufacturing process challenges.
  • Define critical quality attributes and establish robust control strategies via comprehensive process parameters assessment.
  • Design purging studies, parameter assessment, impurity fate/purge studies and PAR/NOR studies (OFAT and multivariate designs)
  • Oversight of manufacture of regulatory starting materials, intermediates and API in support of clinical trial material requirements and commercial process validation.
  • Ensure that regulatory starting materials and API process development and manufacturing activities are conducted in compliance with good manufacturing practices and applicable regulatory requirements by proactively overseeing process development and manufacturing campaigns.
  • Review batch records, process validation plans and protocols, manufacturing campaign reports.
  • Contribute to CMC regulatory submission as a subject matter expert.
  • Prepare technical reports, patent application content, publications and oral presentations as necessary.

Education and experience requirements:
  • Ph.D. in synthetic organic chemistry and at least 5 years’ experience in pharmaceutical industry or similar M.S. degree with at least 8 years of experience.
  • In-depth knowledge of synthetic organic chemistry, chemical process development and efficient process throughput concept.
  • Proven track record of successfully overseeing chemical process development.
  • Proven track record of successfully working with/managing CDMO’ s/CMO’ s.
  • Experience working with analytical and formulation development, quality assurance and control teams.
  • Experience with contributing to CMC sections of clinical trial and marketing applications worldwide.
  • Excellent interpersonal, verbal and written communication skills.
  • Comfortable in a fast-paced environment and able to adjust based upon changing priorities

Tracey Goldthwaite
Senior Vice President

Tracey has more than 20 years experience in the staffing and recruiting industry. She spearheads The Steely Group's Client Services efforts, ensuring superior customer service, communication, and ongoing support to clients and candidates alike. Additional areas of expertise include client relationship management and team building.
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