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 Manufacturing Supervisor, Upstream is responsible for overseeing staff in the execution of production processes for GMP manufacturing operations.

 

 PRINCIPAL RESPONSIBILITIES:

  • Responsible for the daily organization of work flow; delegate responsibilities for shift operations as needed.
  • Responsible for completing the required documentation including, but not limited to, deviation reports, change control, product change over and maintenance task.
  • Responsible for the review and approval of executed manufacturing MBRs Monitor staff during operations as described in standard operating procedures and batch records.
  • Ensure staff complies with all company/regulatory quality systems, safety procedures, and SOPs.
  • Review and ensure errors during manufacturing operations are corrected.
  • Establish priorities, set clear expectations, and demonstrate high standards of work practices.
  • Train, coach, and mentor manufacturing team on manufacturing functions.
  • Promote a safe work environment.
  • Due to the nature of manufacturing, shifts can and will vary. Shift preference may not always be available upon request.
  • Report or status updates to Leadership team.
  • Participate in cross functional meetings, customer’s meetings, and audits etc.

 

KNOWLEDGE, SKILLS & ABILITIES:

  • Must be able to communicate clearly, both verbal and written, in English.
  • Demonstrated expertise using Microsoft Excel and Word.
  • Technical writing skills preferred.
  • Strong organization skills with the ability to prioritize tasks for staff.
  • Ability to work hours necessary to support production and / or maintenance activities.
  • Ability to lift up to 40 lbs. with assistance.
  • Ability to work in confined spaces and near operating equipment.
  • Ability to work in loud noise environments.

 

EDUCATION/EXPERIENCE:

  • BS in Biochemistry, Biology, Chemistry or related field desired.
  • 8+ years GMP operations experience, including 3+ years leading a team/group.
  • Experience in one or more of the following Bioprocess operations (Cell Culture/Production, Harvest and Recovery, or Purification).
  • Equivalent 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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