Are 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 Senior Research Associate, Cell Therapy GMP Manufacturing in our Cambridge office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Senior Research Associate, 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 and a typical day will include:
The primary focus of the Manufacturing Associate role will be cGMP cell therapy manufacturing at Takeda s new cell processing facility in Cambridge, Massachusetts. This position will directly contribute to the successful delivery of novel cell products in support of human clinical trials.
- Execute 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
- Perform operations in a cleanroom environment, using proper controls to assure aseptic processing: includes gowning, cleaning, and isolation procedures
- Perform supporting operations as needed including preparation of consumables, media blending, cleaning, and environmental monitoring
- Complete all daily manufacturing tasks following standard operating procedures and batch document instructions, completing forms, reports, logs and records of equipment, and batches as required
- Ensure all training assignments are complete and up to date, to maintain necessary technical skills and knowledge
- Ensure processing equipment and required materials are available, maintained, and qualified as required for the different manufacturing activities
- Support investigations in manufacturing and technical deviations
- Actively participate in problem identification, problem solving, and change initiatives in cooperation with other teams and functions
- Collaborate with process development scientist to get trained and transfer new processes into cGMP manufacturing
EDUCATION, EXPERIENCE AND SKILLS:
Education and Experience:
- Associates degree in biotechnology, chemistry, pharmacy, engineering or related pharmaceutical science and 4+ years relevant cGMP manufacturing experience
- Bachelors degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science; 2+ years relevant cGMP manufacturing experience
- Masters degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science; 0+ years relevant cGMP manufacturing experience
- Previous hands-on experience in a cGMP or clinically regulated environment is critical
- Knowledge of aseptic processing in ISO 5 biosafety cabinets strongly preferred
- Manufacturing experience in biopharmaceutical operations, preferably involving cell cultures or Regenerative Medicines.
- Experience with culture and handling of human primary cells including T-cells
Knowledge 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 description
- 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 necessary
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
Empowering Our People to Shine
Learn more at takedajobs.com.
No Phone Calls or Recruiters Please.