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Principal Scientist, API Process Development and Manufacturing

  • Job type: Permanent
  • Location: Boston, Massachusetts
  • Salary: US$120000 - US$150000 per year
  • Job reference: 292991/002_1554844876
  • Sector: Pharmacology, EPM Scientific
  • Date posted: 09/04/2019

Title: Principal Scientist- API Process Development and Manufacturing

Location: Greater Boston Area

Salary: Competitive

Company Summary: Rapidly growing pharmaceutical company that has held onto its close-knit team feel looking to add not only skill but personality; is that you? Family is one of the core contributions to success in this company and they are looking to add to their family with a Principal Scientist. Each member is essential to the fundamental success of this passionate, innovative, creative and high achieving pharma company.

MAIN FOCUS: Commercialization of novel therapeutics with over 600 novel compounds.

The Principal Scientist will be responsible for:

  • Develop cost effective API manufacturing processes using an outsourcing model

  • Operation of fundamental process chemistry principles to characterize and solve manufacturing process challenges

  • Explaining critical quality attributes and establish robust control strategies via comprehensive process parameters assessment.

  • Contribute to CMC regulatory submission

  • Ensure that regulatory starting materials and API process development and manufacturing activities are conducted in compliance with GMP and regulatory requirements by proactively overseeing process development and manufacturing operations

  • Design purging studies, parameter assessment, impurity fate/purge studies and PAR/NOR studies (OFAT and multivariate designs)

The Principal Scientist should have the following qualifications:

  • 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.

  • Overseeing chemical process development

  • Working with/managing CDMO's/CMO's

  • Experience with contributing to CMC sections of clinical trial

  • Experience working with analytical and formulation development, quality assurance

Benefits:

  • Fun perks

  • Weekly food deliveries

  • Massage therapist

  • Organized company activities

  • Outings

  • Attractive, comprehensive benefit package

If you are interested in the Principal Scientist role, APPLY!

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