Position: Director, CAR-T Cell Therapy Manufacturing Operations

Reports to: US Site Head of US Durham, NC Site

Location: 4021 Stirrup Creek Drive, Suite 350, Durham, NC

Purpose and Scope of Position:

CARsgen is looking for a Director of CAR-T cell therapy product Manufacturing. The Director will support clinical and commercial manufacture of CT053, CT041 and other CAR-T cell products in CARsgen RTP  facility. The Director will also support facility commissioning and validation of the newly established cell therapy production facility. This person will be a key leader responsible for GMP operations and will serve as a member of the Leadership Team in the US site.

Duties and Responsibilities:

  • Direct and manage the CAR-T cell product Manufacturing team. This includes:
    • Hiring, mentoring, and developing exceptional people, conducting performance reviews, and identifying opportunities for career growth for Managers, Supervisors and Associates.
    • Championing a culture of exceptional teamwork, accountability, continuous improvement, and communication across the organization and multiple sites within CARsgen.
    • Ensuring staff at all levels have and maintain the appropriate level of training necessary for CART cGMP manufacturing in a clinical and commercial facility.
    • Building effective cross-functional relationships with Quality, Supply Chain, MS&T, EHS and Facilities.
    • Ensuring a culture that embraces safety in the work environment and safety of the patients through compliance with company procedures, policies, and cGMP requirements.
  • Oversee operation of the CAR-T cell product Manufacturing Suites. This includes:
    • Establishing goals, tracking and reporting KPIs, and driving continuous improvement through innovation and implementing lean manufacturing initiatives.
    • Implementing operating manufacturing systems that are technically sound, promote effective and efficient operations, and comply with cGMP requirements.
    • Ensuring schedules of the people, facility, equipment, materials, and documents are established and maintained to support the expected capacity for CAR-T manufacture Identifying and mitigating risks in manufacturing operations that could negatively impact delivery of safe and effective therapies to patients.
    • Ensuring on time closure of deviations, CAPAs, and change controls.
    • Championing inspection readiness efforts and initiatives for Right First-Time manufacturing.
    • Establishing team policies, organizational structure, shift structure, and career ladders for Associates, Team Leaders and Managers dedicated to the CAR-T manufacturing suites.
    • Reviewing and approving documents, including standard operating procedures, batch records, material specifications, and validation protocols / reports.
    • Up to 10% travel may be required.

Qualifications and Experience:

  • Bachelor’s degree in relevant science or engineering discipline. Advanced degree preferred.
  • 15+ years’ experience with cGMP biologics manufacturing and/or commercial cell therapy operations including 7-10 years supervising staff at the Associate Director or Director level.
  • Demonstrated track record supporting commercial licensure of CAR T products. International experience preferred.
  • Knowledge of Lean Manufacturing principles required.
  • Advanced understanding and experience with CAR T manufacturing including cell culture, cryopreservation, purification, 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 teams 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 compliance with demonstrated ability to influence and negotiate to meet business requirements.
  • 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.

This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.

 

Equal Employment Opportunity Policy

CARsgen Therapeutics Corporation provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

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