Supervisor, Manufacturing Upstream Jobs

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

PRINCIPAL RESPONSIBILITIES:

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

KNOWLEDGE, SKILLS & ABILITIES:

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

EDUCATION/EXPERIENCE:

• Bachelors in Biochemistry, Biology, Chemistry or related field desired.
• 5+ years GMP operations experience preferred, including 3+ years leading a team/group preferred.
• Equivalent education and experience may substitute for stated requirements.
• Experience in one or more of the following Bioprocess GMP operations: Cell Culture/Production, Harvest and Recovery, or Purification of Mammalian, Bacterial, Viral Vector or Cell Therapy products.

COMPENSATION RANGE:

$94,000 - $129,250 annually

Fluctuations in the job market may necessitate adjustments to pay ranges. Final pay determinations will depend on various factors, including, but not limited to experience levels, knowledge, skills, and abilities.

Benefits available to Team Members include subsidized insurance for the Team Member and designated dependents (medical, vision, dental, life and disability), eligibility to participate in the AGC Biologics 401(k) plan (including a generous matching contribution from the company and immediate vesting), vacation, sick time, and parental leave.

Team Members are also eligible to receive a discretionary annual bonus commensurate to the level of the role. The payout is based on both the company's performance and the Team Member's performance.

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.