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 DescriptionAbout the role:At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.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 Specialist, Manufacturing Science and Analytical Technology in our Cambridge office.How you will contribute:The Cell Therapy manufacturing team in Cambridge, MA, is establishing internal capabilities to manufacture several parallel cell therapy programs for in-human clinical studies. This position’s primary role is to provide scientific and technical input in bringing these programs to patients, with particular focus on qualification and optimization of processes that will be deployed in manufacturing. In this role you will be expected to work within the Manufacturing Science and Analytical Technology (MSAT) Team, working with Development, Technical Operations and Quality to onboard new processes and instrumentation, and engineer them towards robust deployment and implementation in GMP.
Support process and technology transfers, change management, technical deviation, and technical process support for cell therapy projects.
Independently design and execute experiments to support process evaluation and technology transfer.
Identify aspects required for GMP compliance and perform experiments to validate the changes.
Author and execute qualification and validation protocols, working in conjunction with the Technical Operation and Quality Team.
Develop and manage tools and templates that can be used to assess impact and criticality for parameters and attributes.
Revise and edit master batch records as needed using an Electronic Batch Record (EBR) platform.
Support operator training and act as the manufacturing process SME
Author and execute Life Cycle Management process activities, and define/coordinate the related Change Control Activities
Assist in the integration and implementation of digital data enterprises, including electronic Batch Record and data systems.
Minimum Requirements/Qualifications:
Bachelor’s degree in biotechnology, biology, engineering or related pharmaceutical science and 1+ years relevant cell processing or aseptic processing experience in Manufacturing or Process Development (direct experience working with CAR-T is preferred) or Master’s degree in chemistry, biotechnology, biology, engineering or related pharmaceutical science.
Previous hands-on experience in a cGMP or clinically regulated environment is preferred.
Knowledge of aseptic processing in ISO 5 biosafety cabinets strongly preferred.
Manufacturing experience in biopharmaceutical operations, preferably involving cell cultures or Regenerative Medicines.
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.
PHYSICAL 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 onsite 5 days a week.
Ability to work weekends when necessary.
More about us:At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.Takeda Compensation and Benefits SummaryWe understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.For Location:Boston, MAU.S. Base Salary Range:$67,900.00 - $106,700.00The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.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
