Manufacturing Supervisor - Cell Therapy
The Manufacturing Supervisor - Cell Therapy, is part of the Angiocrine manufacturing team that supports clinical production of cell therapies at a Contract Manufacturer. The Supervisor is responsible for managing all cell related tasks to produce clinical products. The Supervisor will ensure execution of production plans at the CMC while managing internal manufacturing cell therapy staff performance to meet operational goals.
Position Role & Responsibilities:
- Manage personnel to execute cell isolation and cell expansion functions at a CMC.
- Provide leadership, guidance, training and direction to staff in alignment with cGMP requirements.
- Collaborates with area managers to ensure accuracy and adherence to production schedules.
- Set daily work activities and roles for staff in collaboration with CMC to meet production demands.
- Coordinate internal product testing and sample submission to contract laboratories.
- Assist area manager with Environmental Monitoring monthly projections and changes.
- Proactively identifies and assesses operational risks, communicates issues to senior management and cross-functional support teams.
- Assists area manager in the design of a Cell Therapy Cell Expansion training plan and execution.
- Perform additional job-related duties as required.
- Extensive experience in adherent cell thawing, expansion, feeding, and harvesting; including cell counting, cryopreservation, sample processing, and intermediate formulations.
- Proficiency in ISO-7 clean room manufacturing and comprehensive knowledge of Good Manufacturing Practices (GMP).
- Experience with generating large tubing assemblies, autoclaving, identifying and use of tubing connectors (MPC, Luers, etc.).
- Experience with 50 L to 100 L bioreactor systems including media supplementation, large bore tubing welding, and making aseptic connections from various vessels to a bioreactor.
- Ability to lead manufacturing teams to adhere to demanding production schedules.
- Authoring, revising, and reviewing of Batch Records, SOPs, and on the job-training documents.
- Experienced in troubleshooting, investigation, and root cause analysis in a cGMP environment.
- Must be able to lift 50 lbs. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Must work with living human cells and various chemicals.
- Due to the nature of production work, overtime and weekend work is a requirement of employment and is variable based on company needs. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Preferred Education and Experience
- Related Bachelor's degree (Biology or Biotechnology)
- 7 + Bio-industry experience with a minimum 5 years cGMP cell culture and/or bioreactors
- Minimum of 2 years’ experience in a leadership role in a cGMP setting.
- Professional experience working for a contract manufacturing organization is preferred.
Additional Desired Skills and Knowledge
- Strong computer skills with Word and Excel and other electronic manufacturing systems.
- Detail oriented team player with effective planning, organization and execution skills.
- Good organization and time management skills.
- Ability to work in a high paced team environment.
- Strong written and verbal skills.
This position is based in San Diego, CA.
Angiocrine is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.