Senior Quality Control Director

3 days ago


Fremont, California, United States Bionova Scientific Inc Full time
Job Summary

Bionova Scientific Inc is seeking a highly experienced Senior Quality Control Director to lead our analytical laboratories across the entire CDMO organization. As a key member of our Quality and Compliance team, you will be responsible for ensuring the success of our analytical laboratories through strategic and tactical leadership.

Key Responsibilities
  • Lead the development and implementation of analytical strategies to support drug development and commercialization.
  • Ensure compliance with global cGMP regulations and expectations surrounding release and stability testing.
  • Collaborate with internal teams and clients to assess program risks and develop analytical strategies.
  • Develop and implement continuous improvement opportunities for QC laboratory operations.
  • 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 field.
  • 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
  • Competitive salary and benefits package.
  • Opportunity to work with a rapidly growing biologics CDMO.
  • Collaborative and dynamic work environment.


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