Jason Mitchell
Summary
Senior Cell Manufacturing Technician and Technical Trainer with extensive experience in cGMP environments for clinical and commercial operations. Proven track record in training personnel, developing compliant SOPs, and ensuring timely batch release through collaboration with QA. Strong focus on GMP compliance and operational excellence, supported by hands-on training and documentation oversight. Expertise in quality assurance standards, problem-solving, and process improvement.
Overview
14
14
years of professional experience
Work History
Manufacturing Technical Trainer
Hims and Hers Health Inc
02.2025 - Current
- Designed and led structured training programs for manufacturing technicians on cGMP principles, batch record completion, aseptic techniques, gowning procedures (ISO 7/5), and controlled document handling.
- Supported QA Batch Release by reviewing batch records and escalating discrepancies for timely resolution.
- Partnered with QA to investigate deviations and execute CAPAs, contributing to improved documentation practices.
- Authored and maintained Standard Operating Procedures (SOPs) and training guides to align with evolving GMP and compliance standards.
- Managed the training matrix and requalification schedules to ensure all personnel met current training requirements.
- Provided regular updates to management on training effectiveness, gaps, and compliance trends.
- Supported documentation audits and ensured GMP readiness of training and batch record files.
Senior Cell Manufacturing Technician
Theragent Inc
03.2022 - 02.2025
- Reviewed and executed batch production records (BPRs), supporting timely and compliant batch disposition.
- Acted as manufacturing floor lead and mentor, coaching peers on proper batch documentation and aseptic operations.
- Collaborated with QA on deviation investigations, CAPA execution, and change controls.
- Participated in controlled issuance and reconciliation of GMP documents, ensuring data integrity and traceability.
- Partnered with cross-functional teams for continuous process improvement and documentation metric tracking.
Cell Therapy Specialist II
Kite Pharma
09.2021 - 02.2022
- Performed end-to-end manufacturing of commercial cell therapies under GMP, including cryopreservation and in-process documentation.
- Reviewed executed batch records and logbooks for compliance prior to QA submission.
- Supported QA and manufacturing tech transfer activities with emphasis on accurate documentation practices.
Cell Therapy Specialist
NKGen Biotech
12.2020 - 09.2021
- Maintained accurate and contemporaneous GMP documentation in both paper and electronic batch records.
- Participated in suite qualification and documentation readiness for GMP release.
- Mentored new technicians on batch record execution and documentation best practices.
Cell Manufacturing Associate II
Dendreon Pharmaceuticals
01.2011 - 10.2020
- Led on-the-job training sessions for aseptic technique, documentation, and process compliance in clinical and commercial manufacturing.
- Conducted manufacturing operations in compliance with Batch Records and SOPs.
- Drafted and reviewed controlled documents, collaborating with QA to enhance release efficiency.
- Supported inventory and kitting of BOM items to ensure manufacturing readiness.
Education
Associate of Science - Process Technology
Coastline College
Skills
- Cell processing equipment
- cGMP compliance
- Batch record review
- SOP development
- Deviation management
- Aseptic techniques
Timeline
Manufacturing Technical Trainer
Hims and Hers Health Inc
02.2025 - Current
Senior Cell Manufacturing Technician
Theragent Inc
03.2022 - 02.2025
Cell Therapy Specialist II
Kite Pharma
09.2021 - 02.2022
Cell Therapy Specialist
NKGen Biotech
12.2020 - 09.2021
Cell Manufacturing Associate II
Dendreon Pharmaceuticals
01.2011 - 10.2020
Associate of Science - Process Technology
Coastline College
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