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Head of Manufacturing Operations

2 months ago

Reston, Virginia, United States CARsgen Therapeutics Full time
Job Summary

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

Key Responsibilities
  • Manufacturing Operations: Lead the manufacturing team in planning and executing CAR-T cell therapy productions to meet clinical needs.
  • Technical Transfers: Collaborate closely with MST and other functions to execute tech transfers to the RTP site.
  • Cleaning and Maintenance: Manage cleaning staff/contractors to ensure manufacturing areas are cleaned per established SOPs.
  • Cross-Functional Collaboration: Build effective cross-functional collaborations with Quality, Supply Chain, MS&T, EHS, and Facilities.
  • Safety and Compliance: Ensure a culture that embraces safety in the work environment and safety of the patients through compliance with company procedures, policies, and cGMP requirements.
  • Continuous Improvement: Set goals, tracking, and KPIs, and drive continuous improvement through operational excellence, technical advancement, and lean manufacturing initiatives.
  • Manufacturing Management Systems: Establish a manufacturing management system that is technically sound, promotes efficient operations, and complies with cGMP requirements.
  • Risk Management: Identify and mitigate risks in manufacturing operations that could negatively impact delivery of safe and effective therapies to patients.
  • Investigations and Compliance: Lead major investigations related to manufacturing. Ensure on-time closure of deviations, CAPAs, and change controls.
  • Team Management: 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.
  • Training and Development: Develop and implement internal training programs for the manufacturing team to improve productivity and ensure compliance.
  • Policy Development: Establish management policies, shift structure, and career ladders for Associates and supervisors.
  • Document Control: Draft, review, and approve various GMP documents, including standard operating procedures, batch records, material specifications, and validation protocols/reports.
Requirements
  • Education: Bachelor's or advanced degree in a relevant science or engineering discipline.
  • Experience: 7+ years' experience with cGMP biologics manufacturing and/or cell therapy operations, including at least 3 years of managerial experience as a manufacturing head.
  • Preferred Experience: Experience in supporting commercial licensure (BLA) of CAR-T or other cell therapy products. Knowledge of Lean Manufacturing and implementation is required.
  • Skills and Qualifications: 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.
  • Leadership and Communication: 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.