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. 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.
The Manager, Manufacturing will be responsible for managing and developing a production team on the night shift with 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.
- This position may manage and be responsible for downstream purification process and downstream operations in large scale.
- This position may manage and be responsible for upstream process from thaw, bioreactors and recovery operations in large scale
- This position may manage and be responsible for media and buffer preparation, furthermore have a cross department functional role for support operations supporting manufacturing activities.
KNOWLEDGE, SKILLS & ABILITIES:
- 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.
- 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.
- 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.
- Responsible for ensuring project plan accomplishes time, quality, and cost objectives.
- Assist with any training required of personnel supporting the project.
- Assist with any training required of end users for process equipment / system improvement projects.
- Participate and hold audits, core customer meetings, site visits, JSC interactions, site inspections and work closely with peers in the organization
- Bachelor’s degree in Chemical or Electrical Engineering and/or equivalent experience.
- 8+ years’ overall experience in clinical or commercial Manufacturing or Process Development with a preference toward biopharmaceutical or other regulated industries.
- 5+ years management experience in clinical or commercial Manufacturing or Process Development with a preference toward biopharmaceutical or other regulated industries.
- Biotech processing equipment (including bioreactors, chromatography, TFF, and CIP). Operational knowledge, clean room operation and cGMP facility regulations.
- Equivalent education and experience may substitute for stated requirements.
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.