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/Senior Manager, Manufacturing is responsible for managing and developing a production team responsible for manufacturing late stage, PPQ and commercial batches. This position is required to ensure execution and completion of projects identified as supporting strategic goals for the site within cost, quality, and time requirements. 

 

PRINCIPAL RESPONSIBILITIES:

  • Manage and be responsible for downstream purification processes and downstream operations in a large scale manufacturing facility.
  • Manage and be responsible for upstream processes from thaw, bioreactors and recovery operations in a large scale manufacturing facility.
  • Manage and be responsible for media and buffer preparation.
  • Participate in the development of the company’s manufacturing strategy.
  • Develop strategies for the manufacturing group to ensure a safe and compliant operation.
  • Oversee, lead and direct all late stage, PPQ and commercial manufacturing activities to ensure products are manufactured according to cGMP and approved procedures.
  • Interface with third parties for products developed, manufactured, tested, processed, packaged, released, and stored by Biologics
  • Manage key performance indicators to meet site and company goals and objectives.
  • Manage manufacturing activities and resolve issues to meet site goals.
  • Develop site policies and procedures which align with company standards.
  • Ensure successful execution of site investment projects to support strategic goals of site.
  • Review and approve recommendations for all process equipment / system investment applications.
  • Responsible for identification of process equipment / system improvement projects to support AGC Biologics operational requirements.
  • Work closely with manufacturing staff in the identification of improvement projects.
  • Assist with any training required of personnel supporting production.
  • Assist with any training required of end users for process equipment / system improvement projects.
  • Participate in audits, core customer meetings, site visits, JSC interactions, site inspections and work closely with peers in the organization.

 

EDUCATION/EXPERIENCE:

  • Bachelor’s degree in Biology and/or equivalent experience, PLUS
  • A minimum of 8+ years management experience in clinical or commercial Manufacturing or Process Development with a preference toward biopharmaceutical or other regulated industries.
  • Experience with Biotech processing equipment (including 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.

 

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.

 

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