Senior Quality Control Director

4 weeks 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 our analytical laboratories through strategic and tactical leadership. This includes leading all analytical development, process development analytical support, and QC testing.

Key Responsibilities:
  • Ensure the success of the analytical laboratories through strategic and tactical leadership.
  • Demonstrate a comprehensive understanding of analytical test methods used in development and commercial product testing.
  • Work closely with internal teams and clients to assess program risks and develop analytical strategies.
  • Support development of new and existing methods for development and commercial programs.
  • Establish clear expectations, metrics and KPIs, to monitor business process performance and stability.
  • Provide leadership, coaching and guidance to the team.
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 also be eligible to participate in certain employee benefit programs and policies that the Company have in effect generally for similarly situated employees at your level.
  • Health benefits at a subsidized rate (90% coverage for employees and 80% coverage for eligible dependents).
  • Life insurance is offered at 2x of annual base pay up to $750,000.
  • Disability programs are 100% covered by Bionova.
  • Full-time employees are eligible to participate in the 401K plan from the first payroll following 30 days of employment.


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