GMP Gene Therapy Manufacturing Associate II

GMP Gene Manufacturing Associate I/II

Responsibilities:
- Perform manufacturing for clinical and commercial materials in a GMP setting, including assembling raw materials
- Execute Master Batch Records (MBR) in accordance with current Good Manufacturing Practices (cGMPs)
- Follow and assist in the development of SOPs, MBRs, deviations, and manufacturing summary reports
- Support initiation and closure of deviations
- Support routine cleaning and changeover procedures for cleanroom suites and equipment
- Participate in and facilitate technology transfer
- Work in a team-based, cross-functional environment to complete production tasks
- Adhere to all safety and regulatory requirements

Qualifications / Requirements:
- Bachelor’s or Master’s degree in biology, biomedical science, or life science
- 1–3 years of experience in a GMP environment
- Aseptic technique experience
- Knowledge of principles and practices of current Good Manufacturing Practices (cGMPs)

Preferred Qualifications:
- Prior cell culture experience in a GMP facility
- Prior Tangential Flow Filtration (TFF) experience

Desired Key Competencies:
- Comfortable in a fast-paced environment; able to adjust workload to changing priorities
- Self-motivated; willing to accept temporary responsibilities as assigned
- Positive interpersonal skills
- Ability to apply scientific principles to solve operational and routine production tasks
- Ability to troubleshoot unit operations
- Self-organized, meticulous hands-on habits, strong attention to detail
- Ability to manage multiple tasks and prioritize workload