Lead Scientist in Process Innovation

2 weeks ago


California, United States EPM Scientific Full time

Lead Scientist - Process Innovation & Development

Join a dynamic team focused on advancing biopharmaceutical processes.

Compensation: Competitive salary along with an attractive bonus and benefits package.

Key Responsibilities:

  • Direct upstream process innovation, downstream operations, and engineering solutions.
  • Manage internal processes and collaborate with both domestic and international partners.
  • Provide strategic guidance across 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 in cross-functional collaboration with senior management in areas such as Quality Control, Analytical Services, Manufacturing, and Regulatory Affairs.
  • Demonstrated leadership in Continuous Process Verification, Process Validation, Material Qualification, and Regulatory Filings.
  • Experience in managing external vendors (CDMOs) and internal research initiatives.
  • Expertise in authoring and strategically navigating IND - BLA/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.


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