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Manufacturing Operations Specialist
1 month ago
We are seeking a skilled Manufacturing Operations Specialist to join our team at AGC Biologics. As a key member of our operations team, you will play a critical role in ensuring the safe and efficient production of biopharmaceuticals.
About the Role:
- Lead the implementation of new manufacturing processes, collaborating closely with our MSAT and Process Development teams.
- Drive process optimization and continuous improvement initiatives to enhance productivity and quality.
- IDentify and implement new technologies to improve current assets, working with users to define requirements, procure, and deploy solutions as needed.
- Collaborate with engineering and validation teams to qualify new equipment and controls, ensuring seamless integration into our operations.
- Coordinate production campaigns, including client communication, batch record review and approval, troubleshooting, deviation management, and CAPA execution.
- Participate in customer meetings, providing updates on manufacturing progress.
- Develop and maintain required documentation, such as SOPs, MPRs, user requirement specifications, manufacturing impact assessments, system deployment checklists, deviation reports, risk assessments, change control, and product change over reports.
- Review GMP documentation to ensure compliance and accuracy.
- Recognize and rectify errors in bioprocess operations before they become failures.
- Recommend and execute projects to reduce risk and increase efficiency, working with clients on process mapping and scale-up.
- Other duties as assigned by management.
Requirements:
- Bachelor's degree in a relevant scientific discipline or equivalent combination of education and experience.
- Level I: 2-4 years' experience in bioprocessing, viral vector, or cell therapy operations; Level II: 5+ years' experience in similar roles.
- Relevant industry experience executing unit operations, completing processing documentation, and working in BSL 2/3 environments.
Compensation:$83,520-$131,000 (dependent on experience and qualifications). Benefits include subsidized insurance, 401(k) matching, vacation time, sick leave, parental leave, and an annual discretionary bonus based on individual and company performance. AGC Biologics is an equal opportunity employer.
About AGC Biologics:AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) delivering high-quality services to clients worldwide. Our commitment to innovation fosters technical creativity to solve complex challenges, including specialization in fast-track projects and rare diseases.
