Director, Cell Therapy GMP Operations

3 months ago

Loma Linda, United States HireMinds Full time

Director, Cell Therapy GMP Operations

Loma Linda, CA


Our client is building a state-of-the-art facility for the research and production of transplantable cell therapy products. They are already well established as a leader in advanced cancer therapies and are looking to continue to innovate within the oncology field.


The Director of Cell Therapy GMP Operations will ensure the quality and safety of all products manufactured through the lab. The position is responsible for producing cell therapy products that comply with federal (including FDA), industry, and Foundation for the Accreditation of Cellular Therapy (FACT) standards and regulations.



Responsibilities:


  • Oversee the day-to-day operations of that lab, including non-investigational and investigational products, product pipelines, product development, delivery, product analysis, quality assurance (QA) testing, outcomes monitoring and reporting.
  • Supervise the processing, manufacturing, process development, testing, storage, distribution of cell therapy products.
  • Ensures that cellular therapy products released by the laboratory meet clinical and quality criteria for infusion in the standard of care and clinical trial settings.
  • Responsible for the development and implementation of standard operating procedures (SOPs).
  • Direct the various departments (TCT, GMP, and storage) of the lab to meet operational needs and develop business plans to support the projects of the laboratory.
  • Maintain and operate the laboratory with current FACT and Good Manufacturing Practice (cGMP) practices as specified by FACT, FDA and similar regulatory and accrediting entities.
  • In collaboration with the Director of the Laboratory, will participate in grants and proposal writing as it relates to TCT-GMP lab.
  • Collaborate daily with clinical team to make critical decisions resulting in the highest quality products that meet the patient’s treatment plan as well as with other various users of the facility.



Qualifications:


  • Bachelor’s degree in a Biological Science or Clinical Laboratory Science required.
  • Master’s degree in the life sciences (e.g. Biologics or Pharmaceutical), or PhD, MD (or equivalent) degree in a related scientific discipline preferred.
  • Five years of experience (leadership experience preferred) in a Transplant Cell Therapy GMP lab or in a related academic or industrial setting (e.g. cellular, biological manufacturing experience, process development and analytical methods) required.
  • Knowledge of Hematopoietic Progenitor Cells/Immune Effector Cells, other cellular products and viral production laboratory processing.
  • Understands Good Manufacturing Practices (cGMPs, GLPs, GDPs) and cellular and gene therapies.
  • Knowledge of federal and state regulations, such as FDA and FACT, and theoretical and technical principals related to transplant cell therapy laboratory and GMP process implementation and maintenance.
  • Understanding of cell processing, viral production, immunology, cell biology, hematology and cell products banking.
  • Remain up to date with literature in the field of cellular therapy.

  • Director, Cell Therapy GMP Operations

    3 months ago

    Loma Linda, United States HireMinds Full time

    Director, Cell Therapy GMP OperationsLoma Linda, CAOur client is building a state-of-the-art facility for the research and production of transplantable cell therapy products. They are already well established as a leader in advanced cancer therapies and are looking to continue to innovate within the oncology field.The Director of Cell Therapy GMP Operations...

  • Head of GMP Operations for Cell Therapy

    2 days ago

    Loma Linda, California, United States HireMinds Full time

    Senior Director of Cell Therapy ManufacturingLocation: ConfidentialOur organization is developing a cutting-edge facility dedicated to the research and production of transplantable cell therapy products. As a recognized leader in advanced cancer treatments, we are committed to driving innovation in the oncology sector.The Senior Director of Cell Therapy...

  • Coordinator-Quality TCT Lab

    2 days ago

    Loma Linda, United States Loma Linda University Medical Center Full time

    - UH: Stem Cell Transplant - (Full-Time, Day Shift) - Our mission is to continue the teaching and healing ministry of Jesus Christ. Our core values are compassion, excellence, humility, integrity, justice, teamwork and wholeness. The Coordinator-Quality TCT Lab works under the supervision of the Supervisor-TCT/GMP Lab to design, develop, evaluate and...

  • Coordinator-Quality TCT Lab

    1 month ago

    Loma Linda, United States Loma Linda University Medical Center Full time

    - UH: Stem Cell Transplant - (Full-Time, Day Shift) - Our mission is to continue the teaching and healing ministry of Jesus Christ. Our core values are compassion, excellence, humility, integrity, justice, teamwork and wholeness. The Coordinator-Quality TCT Lab works under the supervision of the Supervisor-TCT/GMP Lab to design, develop, evaluate and...

  • Head of Respiratory Therapy Operations

    2 days ago

    Yorba Linda, California, United States Clinical Management Consultants Full time

    Position Overview: A prominent healthcare facility in Southern California is seeking a Director of Respiratory Services to enhance their dynamic healthcare team.Role Responsibilities: As the leader of the Respiratory Care department, you will play a crucial role in a comprehensive acute care institution that provides a diverse range of medical services,...

  • Director Respiratory Therapy

    3 weeks ago

    Yorba Linda, CA, United States Clinical Management Consultants Full time

    A Southern California Hospital is actively seeking a Director of Respiratory Services to join their growing healthcare organization. As Hospital Manager Respiratory Care, you will be a vital component of a large acute care facility that offers a wide variety of care such as women’s and children’s services, surgical services, emergency care, family...

  • Director-Planned Giving

    1 month ago

    Loma Linda, United States Loma Linda University Medical Center Full time

    Shared Services: Philanthropy Planned Giving (Full-Time, Day Shift) - Job Summary: The Director-Planned Giving manages a comprehensive planned giving program which results in funds raised through the cultivation and closing of deferred gift agreements and bequests from estate gifts. Is responsible for developing and monitoring departmental initiatives and...

  • Director-Major Gifts

    1 month ago

    Loma Linda, United States Loma Linda University Medical Center Full time

    Shared Services: Philanthropy Strategic (Full-Time, Day Shift) - Job Summary: The Director-Major Gifts (Education) provides strategic leadership support and management of a team of development professionals who raise funds on behalf of the institution's hospitals, schools and programs. Reporting to the AVP of Philanthropy, develops and personally manages a...

  • Family Nurse Practitioner FNP

    4 weeks ago

    Loma Linda, United States Infusion For Health Full time

    Job DescriptionJob DescriptionInfusion for Health is a referral-based infusion center that services all providers in multiple locations in California, Arizona, Nevada, Washington, Colorado, and Missouri. Our center is unique and offers individual comfortable private rooms for our patients. Our mission is to provide exceptional service in the administration...

  • Occupational Therapist-Rehab

    1 month ago

    Loma Linda, United States Loma Linda University Medical Center Full time

    East Campus Hospital: Rehabilitation OP (Full Time, Day Shift) - Our mission is to continue the teaching and healing ministry of Jesus Christ. Our core values are compassion, excellence, humility, integrity, justice, teamwork and wholeness. The Occupational Therapist-Rehab will be responsible for establishing and maintaining a comprehensive and advanced...

  • COTA/L - Loma Linda Post Acute

    1 day ago

    Loma Linda, United States Loma Linda Post Acute Full time

    Loma Linda Post Acute is looking for caring and compassionate Part - Time - COTA to join our Team!At Loma Linda Post Acute, caring is our main concern. Our organization is built on the premise that the most effective way to provide compassionate care is to:Maintain high medical integrityFoster a team spirit among staffCreate friendly, beautiful surroundings...

  • COTA/L - Loma Linda Post Acute

    5 hours ago

    Loma Linda, United States Loma Linda Post Acute Full time

    Loma Linda Post Acute is looking for caring and compassionate Part - Time - COTA to join our Team!At Loma Linda Post Acute, caring is our main concern. Our organization is built on the premise that the most effective way to provide compassionate care is to:Maintain high medical integrityFoster a team spirit among staffCreate friendly, beautiful surroundings...

  • cota/l -

    4 weeks ago

    Loma Linda, California, United States Loma Linda Post Acute Full time

    Loma Linda Post Acute is looking for caring and compassionate Part - Time - COTA to join our TeamAt Loma Linda Post Acute, caring is our main concern. Our organization is built on the premise that the most effective way to provide compassionate care is to: Maintain high medical integrity Foster a team spirit among staff Create friendly, beautiful...

  • COTA/L - Loma Linda Post Acute

    3 weeks ago

    Loma Linda, United States Loma Linda Post Acute Part time

    Loma Linda Post Acute is looking for caring and compassionate Part - Time - COTA to join our Team!At Loma Linda Post Acute, caring is our main concern. Our organization is built on the premise that the most effective way to provide compassionate care is to: Maintain high medical integrity Foster a team spirit among staff Create friendly, beautiful...

  • Supervisor-RN CVL Lab

    5 months ago

    Loma Linda, United States Loma Linda Univ Medical Center Full time

    - UH: Cardiovascular Lab - (Full-Time, Day Shift) -  Our mission is to continue the teaching and healing ministry of Jesus Christ. Our core values are compassion, excellence, humility, integrity, justice, teamwork and wholeness. The Supervisor-RN Cardiovascular Lab is a highly skilled registered nurse that functions effectively in the Cardiovascular Lab...

  • Swing Reach/Turret Operator

    2 months ago

    Mira Loma, United States TEAMONE STAFFING SOLUTIONS LLC Full time

    Job DescriptionJob DescriptionInbound responsibilities include ensuring the proper unloading of trailers, transporting and put-away of product.Outbound responsibilities include the picking, transporting and loading of product into trailers.Routinely conduct product and trailer inspections.Identifying and reporting damaged/infested product.Ensures any...

  • Patient Navigator-RN Bariatric Services

    3 months ago

    Loma Linda, United States Loma Linda University Medical Center Full time

    Job Summary: The Patient Navigator-RN Bariatric Services serves in a Magnet recognized tertiary academic medical center as a key member of the multidisciplinary healthcare team providing comprehensive care for patients in the bariatric medicine and surgery program. Demonstrates a comprehensive body of knowledge related to the specialty practice of bariatric...

  • LVN-Adult Patient Care

    1 month ago

    Loma Linda, United States Loma Linda University Medical Center Full time

    Job Summary: The Licensed Vocational Nurse (LVN) is IV Therapy and Blood Withdrawal Certified in California and caries out responsibilities under the supervision of a Registered Nurse (RN). Provides direct and indirect age-specific and developmentally appropriate patient care as designated within the established multidisciplinary care plan and as ordered by...

  • Perioperative Service Line Coordinator

    2 days ago

    Loma Linda, California, United States Loma Linda University Medical Center Full time

    Position Overview:The Perioperative Service Line Coordinator plays a pivotal role in the operational excellence of our surgical services. This position is integral to our mission of delivering compassionate care while adhering to the highest standards of quality and safety.Key Responsibilities:Assist the Executive Director in overseeing the administrative,...

  • Personal Trainer

    4 weeks ago

    Loma Linda, United States Vim + Vigor Fitness Part time $16 - $30

    Come join our Vim + Vigor Fitness team in Loma Linda! At Vim + Vigor Fitness we know the goals of one member may be completely different from that of another member. Our personal training programs, equipment, turf train areas, and amenities like our HydroMassagers, Red Light Therapy and Tanning, are catered to help everyone that walks through our front...