General Application

AGC Biologics, where your work makes a difference for patients every day. Join a diverse, global team as we create life-changing therapeutic solutions for patients around the world. As industry leaders in the biopharmaceutical space, our growth is only possible thanks to the exceptionally strong partnerships we forge with our employees. By empowering you as a whole person, we create opportunities for you to grow individually and for us all to grow as a team.

 

SUMMARY:

The Supervisor, Manufacturing is responsible for overseeing staff in the execution of production processes for GMP manufacturing operations, monitoring compliance with established processes and standards, and ensuring all safety regulations are strictly adhered. 

 

PRINCIPAL RESPONSIBILITIES:

  • Develop and lead successful manufacturing teams during manufacturing set up and design as well as during routine operations.
  • Lead cross functional teams with Engineering, Project Management, and Process Development.
  • Ensure training of manufacturing staff for critical bioprocess operations, both upstream and downstream.  
  • Identify and drive process optimization solutions.
  • Author and update quality documents, such as Standard Operating Procedures (SOPS) and other technical procedures.
  • Follow-up on production campaigns including client communication, review and approval of batch records, troubleshooting, handling of deviations and CAPAs.
  • Responsible for the daily organization of workflow; 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.
  • Promote a safe work environment.

 

KNOWLEDGE, SKILLS & ABILITIES:

  • Knowledge of Aseptic Techniques and adherence to cGMP practices
  • 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:

  • 5+ years GMP operations experience, including 3+ years leading a team/group
  • BS in Biochemistry, Biology, Chemistry or related field desired
  • Equivalent education and experience may substitute for stated requirements
  • Experience in one or more of the following Bioprocess operations (filtration, purification, cell culture or recovery) a plus

 

We are AGC Biologics, a leading global Contract Development and Manufacturing Organization with a deep commitment to improving life quality through biopharmaceuticals. Join us in our pledge to deliver a reliable and compliant drug substance supply, Right. On time. We offer a competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. For more information, visit www.agcbio.com.

 

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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