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Role Summary
Principal Manufacturing Associate – Team Lead (Second Shift). Oversees daily GMP operations for the CMC-GMP team, serving as the on-the-floor subject matter expert for IMA20x manufacturing processes and activities. Ensures adherence to GMP standards, coordinates cross-functionally, and drives operational excellence in cell therapy production.
Responsibilities
- Knowledge of current cGMP.
- Provide instruction to facilitate workflow, shift activities, and shift exchange ensuring all activities are completed as assigned.
- Provide a safe and controlled work environment.
- Investigate and troubleshoot deviations and unexpected events; act as contact for deviation initiation and completion.
- Maintain competency status to serve as backup for daily manufacturing processes.
- Backup for reviewing executed batch records and documents.
- Coordinate with Training Department to include training needs on the manufacturing schedule.
- Collaborate with MSAT/PD teams to transfer new projects into GMP.
Qualifications
- Bachelor’s Degree in Biology, Biochemistry, Biotechnology or related field.
- Seven or more years of cell therapy manufacturing experience, or four to five years with lead/supervisory experience.
Preferred Qualifications
- Master’s Degree in Biology, Biochemistry, Biotechnology, Healthcare Administration or related field.
- Seven years of cell therapy manufacturing experience.
Skills
- Independent working with minimal supervision on standard tasks; capable of handling non-standard tasks.
- Strong communication: verbal, written; ability to interact with multiple teams; basic presentation skills.
- Problem solving: identify, analyze, and implement solutions within own area.
- Critical thinking; risk identification and process improvement awareness.
- Initiative and proactivity in team and process development.
Education
- Bachelor’s degree (required); Master’s degree (preferred).
Additional Requirements
- Travel may be required between office and manufacturing facility on a daily basis.
- Physical demands include lifting up to 25 lbs, standing/walking, and other related requirements as described.