Manufacturing Associate III

Position Summary

We have an opportunity for a Manufacturing Associate III to join our team and contribute to the production of advanced cell therapies. This role involves supporting and performing GMP manufacturing processes, applying technical knowledge to ensure quality and compliance. The position requires collaboration with cross-functional teams to maintain operational excellence and continuous improvement. The Manufacturing Associate III will play a key role in ensuring the success of both clinical and commercial manufacturing programs.

The Role

• Support manufacturing operations for clinical and commercial cell therapy programs through the execution of cGMP-compliant production activities.
• Coordinate daily production scheduling and resource planning in partnership with Manufacturing leadership.
• Execute and oversee key manufacturing processes, including cell culture, aseptic processing, cell expansion, separation, counting, and cryopreservation.
• Assist with the development, review, and maintenance of manufacturing documentation, including SOPs, work instructions, forms, and protocols.
• Train and mentor Manufacturing Associates in technical operations, aseptic techniques, and cGMP requirements.
• Serve as a subject matter expert in cell therapy manufacturing processes, media preparation, cryopreservation, and Biological Safety Cabinet operations.
• Lead deviation investigations, CAPA implementation, and manufacturing troubleshooting to resolve process and equipment issues.
• Drive continuous improvement initiatives to enhance process efficiency, quality, compliance, and operational performance.
• Support validation and qualification activities, including equipment, cleanroom, calibration, and process-related protocols.
• Maintain inspection readiness by ensuring compliance with cGxP, FDA, safety, cleaning, documentation, and facility/equipment requirements, including batch record and logbook review.
• Perform additional duties as assigned.

The Candidate

Minimum Requirements

• High School Diploma with 4–6 years of GMP manufacturing experience, OR Associate degree in a scientific, engineering, or biotechnology discipline with 4 years of related experience, OR Bachelor's degree in a scientific or engineering discipline with 3 years of relevant experience.
• Experience supporting biologics, cell therapy, or advanced therapy manufacturing processes, including CAR-T, CRISPR, or related technologies.
• Hands-on experience with cell culture, cell expansion, cell counting, cell separation, cryopreservation, and aseptic processing in GMP-regulated environments.
• Proven ability to work in Grade A, B, C, and D cleanrooms while maintaining aseptic gowning and contamination control standards.
• Strong knowledge of FDA regulations, GMP requirements, aseptic techniques, and Good Documentation Practices (GDP).
• Technical expertise with manufacturing equipment and technologies, including bioreactors, incubators, centrifuges, electroporation systems, controlled-rate freezers, cell selection platforms, and single-use technologies.
• Experience operating, troubleshooting, and maintaining cell therapy manufacturing equipment, including cell counters, separation systems, and liquid nitrogen storage systems.
• Strong communication, technical writing, leadership, and interpersonal skills, with the ability to collaborate across cross-functional teams, mentor peers, drive continuous improvement initiatives, and excel in a fast-paced manufacturing environment with evolving priorities and deadlines.
• Physical requirements: Ability to work in GMP-controlled environments while fully gowned, including prolonged standing or sitting, handling human-derived materials, lifting or moving up to 50 lbs., performing cleaning and sanitation activities, maintaining accurate documentation, working safely around biohazardous materials and manufacturing equipment, and meeting required visual acuity standards.

Preferred Skills & Background

CDMO experience highly preferred.