Federation of American Societies for Experimental Biology (FASEB)

Process Validation Manager, CGT

AGC Biologics
Longmont, Colorado, United States
11 days ago


AGC Biologics is a leading global Contract Development and Manufacturing Organization, with a deep commitment to improving life quality by bringing new biopharmaceuticals to market. Because of our dedication to building and empowering our internal teams, AGC Biologics is an innovative leader in the industry with an extensive network of cGMP facilities in the US, Europe and Asia. As such, we deliver a deep expertise, dynamic solutions and technologies, as well as customized services for the scale-up and cGMP manufacturing of protein-based therapeutics and cell and gene therapies. We forge exceptionally strong partnerships with our clients, and we never lose sight of our pledge to deliver a reliable and compliant drug substance supply, Right, On time. For more information, visit www.agcbio.com.


The Process Validation Manager of our Cell Gene Therapy facility in Longmont, CO will be responsible for leading our process validation activities together with your team, providing coordination of all process validation related activities. This includes developing the validation strategy, preparing, executing and finalizing all documentation associated with process validation according to authority guideline principles.   



  • Managing the flow of operations in the team – balancing the work over several projects simultaneously
  • Execute all responsibilities as the validation owner to ensure compliance to appropriate regulatory requirements and industry standards while maximizing efficiency
  • Communicating clear instructions and feedback to team members and listening to team members' feedback
  • Facilitating and/or providing training for team members
  • Providing innovative solutions to complex problems surrounding the development and manufacturing processes
  • Oversee the validation lifecycle activities
  • Supporting requests for technical assistance from the rest of the AGC biologics organization globally


  • ​Knowledge of the Quality by Design methodology
  • FMEA/risk analysis methodology
  • Able to identify and respond to complex challenges, interpret complex data and draw valid conclusions
  • Demonstrated leadership skills as well as team building and mentoring skills


  • Have 5+ years of biopharmaceutical process validation experience
  • Have some leadership experience and the ability to be the professional sounding board to your team.
  • Strong communication skills as will communicate with members of other departments/sites within the AGC network a well as customers
  • Must have experience with and demonstrated understanding of Good Manufacturing Practices (GMP) and applicable regulations (e.g., ICH Q7A, 21 CFR Part 211, etc.). 
  • Must have experience writing, reviewing and approving GMP documentation. 
  • Advanced computer skills including Excel and Word.    


$110,600 - $143,800

AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances

Job Information

  • Job ID: 58633783
  • Location:
    Longmont, Colorado, United States
  • Company Name: AGC Biologics
  • Position Title: Process Validation Manager, CGT
  • Job Function: Manager
  • Job Type: Full-Time
  • Salary: $110,600.00 - $143,800.00 (Yearly Salary)
Boulder , CO , US

AGC Biologics is a leading global Contract Development and Manufacturing Organization (CDMO), providing world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), viral vectors and genetically engineered cells. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast track projects for orphan drugs and rare diseases.   AGC Biologics purchased a state-of-the-art commercial m...

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