Manager/Senior Manager, GMP Operations - Cell Therapy

Company: Takeda Pharmaceutical
Location: Jersey City
Posted on: November 19, 2021

Job Description:

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 and . I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionAre you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda.- Join us as a Manager, GMP Operations, Cell Therapy in our Cambridge office.At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.Here, everyone matters and you will be a vital contributor to our inspiring, bold mission.As a Manager/ Senior Manager, GMP Operations, working on the Cell Therapy GMP Manufacturing team, you will be empowered to support the manufacturing of Takeda's Cell Therapy products and work with cross-functional peers to support clean room activities.-POSITION OBJECTIVES:The focus of the GMP Operations Manager role will be to oversee cGMP cell therapy manufacturing at Takeda's new cell processing facility in Cambridge, Massachusetts. Additionally, this role will represent MFG as lead or support for Technology transfer for early/ late stage clinical Cell Therapies to and from the cGMP Facility. This position will directly contribute to the successful delivery of novel cell products in support of human clinical trials.---------------------------------POSITION ACCOUNTABILITIES:Routine GMP Operations

• Lead and support execution of unit operations for manufacturing of patient therapies according to standard operating procedures and cGMP, regulatory and safety requirements. Duties include basic cell culture as well as specialized techniques for cell selection, activation, transduction, and purification
• Oversee a team performing operations in a cleanroom environment, using proper controls to assure aseptic processing: includes gowning, cleaning, and isolation procedures
• Ensure all daily manufacturing tasks are completed following standard operating procedures and batch document instructions, completing forms, reports, logs and records of equipment, and batches as required
• Train, supervise and mentor GMP production personnelTechnology Transfer
  • Lead or support Technology Transfer as the receiving unit including participation in tech transfer team(s), generation of related documents including protocols, training plans, batch records, SOPs, reports and/ or regulatory documents such as IND
  • Lead or support Technology Transfer as the sending unit including participation in tech transfer team(s), generation of training materials, leading external training, participation as the SME in external document preparation including protocols, training plans, batch records, SOPs, reports and/ or regulatory documentsQuality Systems, Training and Compliance
    • Confirm all training assignments for team are complete and up to date, to maintain necessary technical skills and knowledge
    • Author or support investigations in manufacturing and technical deviations
    • Actively participate in problem identification, problem solving, and change initiatives in cooperation with other teams and functions
    • Work with cross functional teams to review internal processes and support continuous improvement activitiesEDUCATION, EXPERIENCE AND SKILLS:Education and Experience:Manager Requirements
      • Bachelors degree in biotechnology, biology, engineering or related pharmaceutical science and 7+ years relevant cell processing experience (4+ years direct experience working with CAR-T) in Manufacturing or Process Development.
      • Masters degree in chemistry, biotechnology, biology, engineering or related pharmaceutical science and 5+ years relevant cell processing experience (4+ years direct experience working with CAR-T) in Manufacturing or Process Development.
      • Previous hands-on experience in a cGMP or clinically regulated environment is required.
      • Knowledge of aseptic processing in ISO 5 biosafety cabinets strongly preferred.
      • Manufacturing experience in biopharmaceutical operations, preferably involving cell cultures or Regenerative Medicines.
      • Previous people management experience requiredSenior Manager Requirements
        • Bachelors degree in biotechnology, biology, engineering or related pharmaceutical science and 10+ years relevant cell processing experience (4+ years direct experience working with CAR-T) in Manufacturing or Process Development.
        • Masters degree in chemistry, biotechnology, biology, engineering or related pharmaceutical science and 8+ years relevant cell processing experience (4+ years direct experience working with CAR-T) in Manufacturing or Process Development.
        • Previous hands-on experience in a cGMP or clinically regulated environment is required.
        • Knowledge of aseptic processing in ISO 5 biosafety cabinets strongly preferred.
        • Manufacturing experience in biopharmaceutical operations, preferably involving cell cultures or Regenerative Medicines.
        • Previous people management experience requiredKnowledge and Skills:
          • Teamwork - Ability to work well in a highly cross-functional team environment
          • Communication - Able to expresses one's self clearly and concisely within team; documents issues and/or concerns concisely with colleagues; timely and effectively communicates issues to supervisor
          • Analytical and Problem Solving Skills - Able to troubleshoot critical issues or problems and determine causes and possible solutions using appropriate information
          • Organization - Exercises good time management and prioritization skills and can successfully manage multiple tasks simultaneously
          • Motivated - Self-motivated and willing to accept temporary responsibilities outside of initial job descriptionPHYSICAL REQUIREMENTS:
            • Work is generally performed in a GMP manufacturing facility and may require extended periods of standing (4 hours)
            • Ability to lift, pull, or push equipment requiring up to 25-50 lbs. of force
            • Ability to work weekends when necessaryAbsent an approved religious or medical reason, all US office-based and lab-based Takeda employees who work fully on-site or in a hybrid model (as determined by Takeda) must be fully vaccinated to work at a Takeda site or to engage with Takeda colleagues or anyone else on behalf of Takeda. US field-based employees must be fully vaccinated as a condition of employment, absent an approved religious or medical reason. US employees who work at a Takeda manufacturing facility, and those who work at a BioLife center or BioLife lab, may be subject to different guidelines. If you are contacted by a Takeda recruiter about your job application, we encourage you to seek more information on the applicable guidelines for the Business Unit/Function to which you have applied.WHAT TAKEDA CAN OFFER YOU:
              • 401(k) with company match and Annual Retirement Contribution Plan
              • Tuition reimbursement
              • Company match of charitable contributions
              • Health & Wellness programs including onsite flu shots and health screenings
              • Generous time off for vacation and the option to purchase additional vacation days
              • Community Outreach Programs#LI-KD1This job posting excludes CO applicants.EEO StatementTakeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.LocationsBoston, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time

Keywords: Takeda Pharmaceutical, Jersey City , Manager/Senior Manager, GMP Operations - Cell Therapy, Executive , Jersey City, New Jersey