Head of Manufacturing Operations

2 days ago

Reston, Virginia, United States CARsgen Therapeutics Full time
Job Title: Head of Manufacturing

CARsgen Therapeutics is seeking a highly experienced and skilled Head of Manufacturing to lead our daily clinical manufacturing activities. This role will report to the head of Technical Operations and be responsible for managing the manufacturing team, ensuring GMP compliance, and championing initiatives to improve quality and efficiency.

Key Responsibilities:
  • Lead the 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 the 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 patients through compliance with company procedures, policies, and cGMP requirements.
  • Set goals, track, and drive continuous improvement through operational excellence, technical advancement, and lean manufacturing initiatives.
  • Establish a manufacturing management system that is technically sound, promotes efficient operations, and complies with cGMP requirements.
  • Ensure schedules of people, facility, equipment, materials, and documents are well organized to support 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.
  • Develop and implement internal training programs for the manufacturing team to improve productivity and ensure compliance.
  • Establish management policies, 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.
Requirements:
  • Bachelor's or advanced degree in a 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, including 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 a 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.

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