Director, Manufacturing T Cell Therapeutics Research Laboratory
Job Title: Director, Manufacturing T Cell Therapeutics Research Laboratory
This position supports our exciting CAR-T cell Therapy Program!
About CAR-T Cell Therapy:
City of Hope continues to be at the forefront of a powerful form of immunotherapy known as chimeric antigen receptor (CAR) T cell therapy. Using this approach, immune cells are taken from a patientâ€™s bloodstream, reprogrammed to recognize and attack a specific protein found in cancer cells, then reintroduced into the patientâ€™s system, where they get to work destroying targeted tumor cells. To learn more about this exciting therapy, please visit https://www.cityofhope.org/research/car-t-cell-therapy
The T Cell Therapeutics Research Laboratory (TCTRL) overseen by Stephen Forman, M.D., is a fast-paced lab leading the way with cutting edge technology to develop innovative clinical trials and novel therapeutic strategies in immunotherapy. Our translational science focus is to move promising novel laboratory technologies and treatments into early phase clinical studies. TCTRL has a proven track record of translating science to treatments and has successfully supported phase I clinical studies with clinical-grade materials developed and manufactured in our by GMP facility under its integral quality systems and regulatory affairs programs.
The Director, TCTRL Manufacturing, will supervise cGMP manufacturing and process development for the production of CAR T cell products, providing scientific, technical, and supervisory leadership. This key leadership position is critical to ongoing clinical trial involving CAR T cell therapies.
Key Responsibilities include:
- Develop, manage & lead a team responsible for ensuring successful cGMP manufacturing of CAR T cell products as part of Phase I/II clinical trials.
- Responsible for hiring, mentoring and developing exceptional manufacturing team. Provide necessary training and ongoing coaching, discipline and recognition of direct staff. Champion a culture of exceptional teamwork and communication.
- Manage, plan, and review operations for assigned staff, including responsibility for coordinating, scheduling and assigning work, and maintaining facility's standards.
- Establish team policies, organizational structure, shift structure, and career ladders.
- Ensure a culture that embraces the safety of the work environment and the safety of the patients by compliance with institutional procedures and policies, and cGMP requirements
- Demonstrate strong supervisory skills and contributes to the achievement of company and departmental goals and objectives.
- Investigate and resolve problems, identifying root cause and proposing process improvements through clear communication to senior management
- Establish department objectives/goals, track and report productivity, and drive continuous improvement efforts.
- Develop objectives/goals for direct reports. Routinely monitor progress against those objectives and conduct performance reviews on an annual basis. Provide timely and professional feedback to direct reports and management.
- Coordinate daily activities of the work unit, assigns tasks to manufacturing associates to ensure completion of daily and weekly manufacturing schedules.
- Ensure staffing, facilities, equipment, materials, and documents are adequate, established and maintained to support the capacity/throughput of the facility and changing priorities.
- Facilitate smooth transition of information between individuals, shifts, and supporting departments.
- Work closely with all operations support functions (e.g., Quality Assurance, Quality Control, Facilities, Process Development, Project Management) to ensure that objectives are met on schedule.
- Interact with outside vendors, external partners, and senior management, as required.
- Participate in multi-functional project teams, as necessary.
- Possess strong working knowledge of the regulatory compliance requirements for the commercial production of biologics. Remains current regarding current Good Manufacturing Practices (cGMP) guidelines and develops and/or modifies production methods to fully address compliance issues.
- Ensure staff are working in full compliance with regulatory standards (e.g., cGMP) and applicable health and safety regulations (e.g., OSHA).
- Ensure all production equipment is properly working and production processes meet quality standards for cGMP compliance.
- Work with manufacturing and regulatory staff to create, revise, and edit SOPs, batch records and raw material and product specifications as needed.
- Review and approve in a timely manner documentation, including but not limited to: training records, batch records and the Certificates of Analysis of the product, SOPs and batch record versions, equipment and other log books, and validation documentation.
- Oversee implementation of manufacturing process development and improvements.
- Identify and mitigate risks in manufacturing operations that could negatively impact delivery of safe and effective therapies to patients.
- Investigate production variances/failures to identify root causes. Initiate corrective and preventive actions.
- Direct logistical planning.
- Develop, implement, and manage experimental design and data collection.
- Ability to critically interpret experimental results and analyze scientific data with accuracy and precision.
- Effectively & efficiently communicate results internally and externally. Prepare data/metric reports for internal use, regulatory filings, grant applications, and scientific publications and conferences.
- Drive innovation. Develop and implement tools, systems, and processes to improve cell manufacturing processes/operations, including but not limited to: improved quality, better efficiency, reduced operating costs.
- Establish and lead teams to source, vet, qualify, and implement enabling technologies including equipment, supplies, reagents, infrastructure, and IT.
- Collaborate on process development and successfully transfer processes from development stage to GMP production. Oversee validation/implementation of manufacturing processes and scale-up.
- Advanced degree (PhD preferred) in field of biological science, engineering or related scientific field
- Minimum of 5 years of experience working with human T-cells, primary human cells, immune systems or similar biological systems.
- Understanding of chimeric antigen receptor (CAR) based T-cells, specifically T cell activation, T cell-mediated lysis and T cell exhaustion.
- Minimum of 2 years of experience in cGMP cell therapy and/or biological product manufacturing, preferably with emphasis on immunological systems, cell therapy, gene therapy, and individualized patient therapies.
- Demonstrated experience building, training, and leading exceptional teams.
- Minimum of 2 years supervisory experience and leading teams of greater than 5 people in a highly matrixed and milestone-driven environment.
- Hands on experience with drug product manufacturing scale up, technology transfer, and product process optimization.
- Strong knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing.
- Experience in authoring and reviewing documents for regulatory review and other regulatory filings (e.g., FDA).
About City of Hope
City of Hope is an independent research and treatment center for cancer, diabetes and other life-threatening diseases. Designated as one of only 49 comprehensive cancer centers, the highest recognition bestowed by the National Cancer Institute, City of Hope is also a founding member of the National Comprehensive Cancer Network, with research and treatment protocols that advance care throughout the world.
City of Hope is located in Duarte, California, just northeast of Los Angeles, withcommunityclinicsthroughout Southern California. It is ranked as one of "America's Best Hospitals" in cancer by U.S. News & World Report . Founded in 1913, City of Hope is a pioneer in the fields ofbonemarrowtransplantation, diabetes and numerous breakthroughcancerdrugsbased on technology developed at the institution.
City of Hope is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, or status as a qualified individual with disability.
#LI-DB1 #CAR-T #CAR_T #TCELL #CELLMANUFACTURING #IMMUNOTHERAPY #GMP