Purpose and Scope of Position:
CARsgen is looking for a Head of Manufacturing. The role will report to the head of Technical Operations and is responsible for managing the daily clinical manufacturing activities of CT053, CT041 and other CAR-T cell products at the US Durham, NC facility. The position will also supervise the manufacturing staff, ensure GMP trainings and compliance, plan the productions, and champion various initiatives aimed at improve quality and efficiency. This position will also play a key role in tech transfers. This person is a key member of the site leadership and will serve as an operating steward the US site.
Duties and Responsibilities:
- Lead manufacturing team in planning and executing CAR-T cell therapy productions to meet clinical needs.
- Collaborate closely with MST and other functions to execute tech transfers to RTP site
- Manage cleaning staff/contractors to ensure manufacturing areas are cleaned per established SOPs
- Build effective cross-functional collaborations with Quality, Supply Chain, MS&T, EHS and Facilities.
- Ensure a culture that embraces safety in the work environment and safety of the patients through compliance with company procedures, policies, and cGMP requirements.
- Set goals, tracking and KPIs, and driving continuous improvement through operational excellence, technical advancement and lean manufacturing initiatives.
- Establish a manufacturing management systems that are technically sound, promote efficient operations, and comply with cGMP requirements.
- Ensure schedules of the people, facility, equipment, materials, and documents are well organized to support the expected capacity for CAR-T manufacture. Identify and mitigate risks in manufacturing operations that could negatively impact delivery of safe and effective therapies to patients.
- Lead major investigations related to manufacturing. Ensure on time closure of deviations, CAPAs, and change controls.
- To shape and develop a fit for purpose department organization and an inclusive high performing business team, continuously improve team efficiency through effective management methods, such as fair and objective performance evaluation on the team members and effective internal communication.
- Develop and implement the internal training programs for the manufacturing team to improve the productivity and ensure compliance
- Establish management policie, shift structure, and career ladders for Associates and supervisors
- Draft, review and approve various GMP documents, including standard operating procedures, batch records, material specifications, and validation protocols / reports.
- Up to 5% travel may be required.
Qualifications and Experience:
- Bachelors or advanced degree in relevant science or engineering discipline
- 7+ years experience with cGMP biologics manufacturing and/or cell therapy operations including at least 3 years managerial experience as manufacturing head.
- Experience in supporting commercial licensure (BLA) of CAR T or other cell therapy products is preferred.
- Knowledge of Lean Manufacturing and implementation is required.
- In-depth knowledge and experience with CAR T manufacturing process or other cell therapy processes, which includes cell culture, cryopreservation, filling, and aseptic processing.
- Knowledge of cGMP/FDA regulated industry, including direct experience with ex-US Health Authorities (EMA, Health Canada, PDMA) and inspections, preferably for commercial CAR T products.
- Ability to work effectively in cross-functional setting to deliver results and meet business objectives.
- Experience with reviewing and approving SOPs, Batch Records, Change Controls, deviations and CAPAs.
- Strong background in training and GMP compliance
- Background to include an understanding of biology, chemistry, medical or clinical practices
- Previous experience managing, coaching, and providing direction to manufacturing and technical staff in a commercial biopharmaceutical manufacturing setting.