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Takeda Pharmaceuticals
Boston, MA, United States
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Job Source: Takeda PharmaceuticalsTakeda Pharmaceuticals
Boston
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job Source: Takeda PharmaceuticalsAmerican Society of Gene & Cell Therapy
Burlington, MA, United States
Account Executive/Director, Cell & Gene Therapy Catalent Cell and Gene Therapy is a leading provider for CDMO services from its sites in Gosselies (Belgium), Düsseldorf (Germany), Maryland, and Princeton. We have ambitious growth plans for our business and are expanding our teams quickly. You will join our dynamic Business Development Teams for Eur
Job Source: American Society of Gene & Cell TherapyIntellia Therapeutics
Cambridge, MA, United States
Why Join Intellia? Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases. Beyond our science, we live our four core values: One, Explore, Disrupt, Deliver and feel strongly that you can achieve more at Intellia. We have a single-minded determ
Job Source: Intellia TherapeuticsDana-Farber Cancer Institute
Boston, MA, United States
Job ID: 40562 Location: 450 Brookline Ave, Boston, MA 02215 Category: Medical Technologist Employment Type: Full time Work Location: Hybrid: 2-3 days onsite/week Overview The Cell Therapy Coordination job family provides specialized adult and pediatric patient and resource scheduling for high complexity, high risk clinical services supp
Job Source: Dana-Farber Cancer InstituteDana-Farber Cancer Institute
Boston, MA, United States
The Cell Therapy Coordination job family provides specialized adult and pediatric patient and resource scheduling for high complexity, high risk clinical services supporting hematopoietic stem cell transplant patients and donors, and immune effector cell therapies including CAR-T. Following exceptionally tightly defined procedures as a member of a
Job Source: Dana-Farber Cancer InstituteCullinan Therapeutics
Cambridge, MA, United States
Summary: We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Director/Sr. Director, Global GMP Quality Assurance. The Director/Sr. Director, Global GMG Quality Assurance will act as the Head of GMP QA and has overall responsibility for establishing QMP QA quality objectives, managing the GMP QA team
Job Source: Cullinan TherapeuticsDana-Farber Cancer Institute
Boston, MA, United States
Job ID: 38522 Location: 450 Brookline Ave, Boston, MA 02215 Category: Administration Support/Customer Service Employment Type: Full time Work Location: Onsite: 100% onsite Overview The Cell Therapy GXP Educational Program Director is a key leadership position that will develop and implement the Cell Therapy GXP Workforce Training Progra
Job Source: Dana-Farber Cancer InstituteBoston, MA, United States
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.*
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Email Alert for Director, Cell Therapy GMP Operations jobs in Boston, MA, United States
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