Senior Quality Control Director

18 hours ago


Fremont, California, United States Bionova Scientific Inc Full time
Job Title: Senior Quality Control Director

Bionova Scientific Inc is seeking a highly experienced Senior Quality Control Director to lead our analytical laboratories across the entire CDMO organization.

Job Summary:

The Senior Quality Control Director will be responsible for ensuring the success of Bionova Scientific's analytical laboratories through strategic and tactical leadership. This includes leading all analytical development, process development analytical support, and QC testing activities.

Key Responsibilities:
  • Lead the analytical laboratories to ensure compliance with global cGMP regulations and expectations.
  • Develop and implement analytical strategies to support development and commercial programs.
  • Work closely with internal teams and clients to assess program risks and develop analytical strategies.
  • Support the development of new and existing methods for development and commercial programs.
  • Establish clear expectations, metrics, and KPIs to monitor business process performance and stability.
Requirements:
  • Advanced degree in Pharmaceutics, Biochemistry, Physical Chemistry, Organic Chemistry, Biochemical Engineering, or related experience.
  • 10+ years of experience leading and managing large teams in a AS/QC environment.
  • Experience with direct interaction with global regulatory agencies.
  • Experience with analytical method validation and optimization for drug substance/drug product release and stability testing.
  • Extensive experience and knowledge of GMPs.
Benefits:
  • Full-time employees will be eligible to participate in certain employee benefit programs and policies.
  • Healthcare, Dental, and Vision insurance.
  • Life Insurance and Disability Program.
  • Retirement Plan (401K).
  • Paid time off.
  • Holidays.


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