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Lead Scientist in Process Innovation

2 months ago

California, United States EPM Scientific Full time

Principal Scientist - Process Development & Manufacturing

Location: Greater LA Area

Compensation: Competitive salary with exceptional bonus and benefits package

Key Responsibilities:

  • Direct upstream process innovation, downstream operations, and engineering solutions
  • Manage internal activities and coordinate with domestic and international partners
  • Provide strategic direction for multiple projects from initial discovery through to commercialization and launch
  • Collaborate with R&D, CMC, Manufacturing, Quality Assurance, and Business Development teams

Required Qualifications:

  • Proven experience working collaboratively with senior management across various functions (Quality Control, Analytical, Manufacturing, Regulatory Affairs, Business Development, etc.)
  • Demonstrated leadership in Continuous Process Verification, Process Validation, Material Qualification, and Regulatory Submissions
  • Experience managing outsourced vendors (CDMOs) and overseeing internal research activities
  • Expertise in authoring and strategically managing IND, BLA, and MAA submissions
  • Advanced degree (M.S. or Ph.D.) in Bioengineering, Chemical Engineering, or a related scientific discipline with a minimum of 10 years of relevant industry experience