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Manager/Sr. Manager Manufacturing Services

Company: AGC Biologics
Location: Longmont
Posted on: August 6, 2022

Job Description:

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.

Summary

The Manager/Sr. Manager of Manufacturing Services is responsible for overseeing the manufacturing supporting team to enable the efficiency of LGT Manufacturing teams. Specific responsibilities include managing the manufacturing compliance and deviation investigation team, the manufacturing training team, the manufacturing project portfolio, and manufacturing operational excellence.

Principal Responsibilities

  • Create and drive a vision for manufacturing support and process excellence in manufacturing at the Longmont site.
  • Oversee a team of direct reports whose responsibilities include manufacturing compliance, manufacturing training, operational excellence, and the manufacturing project portfolio.
  • Owning the process to identify improvement opportunities, manage the projects, and implement the solutions.
  • Ownership of the manufacturing Change Controls with the support of Manufacturing managers.
  • Own and drive manufacturing KPI around CAPA delivery, Change Control, deviation investigation delivery, training, and project management.
  • Communicate with manufacturing managers to ensure deviation investigation is closed on time.
  • Develop and support the leads and the team members on the different functions within manufacturing services.
  • Support production scheduling and planning.
  • Managing and planning resources to effectively and efficiently support LGT site manufacturing strategy.
  • Manage contract cleaning team for GMP and Non-GMP areas.
  • Manage consumable gowning supply for GMP process.
    Education/Experience
    • Manager Role: BS / BA degree in life sciences or related field with 8+ years of industry experience; or Master's degree with 6+ years of industry experience
    • Sr. Manager Role: BS / BA degree in life sciences or related field with 10+ years of industry experience; or Master's degree with 8+ years of industry experience
    • A minimum of 5+ years management experience in clinical or commercial Manufacturing or Process Development with a preference toward biopharmaceutical or other regulated industries
    • Direct experience communicating with regulatory inspectors during GMP inspections
    • Experience supporting clinical and commercial GMP operations
    • Experience with Biotech processing equipment (examples include biological safety cabinets, bioreactors, chromatography, TFF, and CIP)
    • Operational knowledge, clean room operation and cGMP facility regulations
    • Equivalent combination of education and experience may substitute for stated requirements
      Compensation Range

      $97,900- $155,400

      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.

Keywords: AGC Biologics, Longmont , Manager/Sr. Manager Manufacturing Services, Executive , Longmont, Colorado

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