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.
In this role, the Manufacturing Associate II or III will be responsible for implementing and troubleshooting of Cell Therapy/Bioprocess operations in compliance with established processes and standards. The successful candidate will possess the necessary skills, expertise, to work efficiently with quality and safety in mind.
ESSENTIAL JOB DUTIES/RESPONSIBILITIES
- Assist in the production of clinical and commercial products under cGMP conditions through the use of SOPs and Batch Records.
- Completing documentation required by process transfer protocols, validation protocols, standard operating procedures, and batch records.
- Performing tasks in a manner consistent with the safety policies, quality systems, and GMP requirements.
- Completing training assignments to ensure the necessary technical skills and knowledge.
- Ensure clean rooms are maintained in an organized and ready state.
- Assist with troubleshooting Cell Therapy operations (aseptic processing, cell isolation, selection, culturing cryopreservation, upstream processing, downstream processing).
- Interface with Quality Assurance and Shift Supervisors on production tasks.
- Collaborates with support groups on recommendations and solving technical and operational problems.
- Analyzes issues and makes decisions based on standardized processes and procedures under close supervision
- Participate in compliance and technical development projects
- Work closely with Quality Assurance, Shift Supervisors on Quality Events
- Support Manufacturing process operations which may include the authoring/revising of SOPs, Batch Records, Reports and material ordering.
- Create and maintain training materials and curricula that support continuous improvement in the cGMP manufacture of cell therapy products.
- Provide training to team members on the set-up and use of equipment, process and material flows, as assigned.
- Work with production planning/leadership to execute daily unit operations per the schedule that includes people, product, and material flow across multiple shifts.
- Other duties as assigned
- Proactively identify opportunities for improvements in process, safety, quality and cost.
- Ability to collaborate and thrive in a fast pace work environment, working across teams effectively.
- Explains complicated information and effectively lays out variations of alternatives to consider.
- Must be able to gown into a cleanroom environment daily and perform aseptic processing. This may include, but not limited to: safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hairnets, gloves, and hearing protection.
- Must be comfortable handling human blood components in an ISO 5 environment and working in biosafety cabinets.
- Experience with some or all of the following: cGMP manufacture and/or process development for CAR T, TCR, NK, cellular therapies, AAV, LV, RV.
- Experience in cell therapy manufacturing, including manual and automated processes, open and closed operations.
- Proficiency in aseptic technique
- BS/BA degree and 2+ years of relevant experience or 6-8 years of GMP relevant experience for a Manufacturing Associate II.
- BS/BA degree and 5+ years of relevant experience or 8+ years of GMP relevant experience for a Manufacturing Associate III.
- High School Diploma or equivalent education and experience may substitute for stated requirements.
$28.73 - $49.55 hourly
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.