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Job Description
About 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.
As a Senior Specialist, Manufacturing Supply Operations, Cell Therapies, working on the Cell Therapy GMP Manufacturing Supply Operations 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.
How you will contribute:?
The role will support the routine operations of the cell therapy manufacturing team and report to the Senior Manager of Manufacturing Supply Operations at Takeda's clinical cell processing facility in Cambridge, Massachusetts. The position will provide support services to the team during a manufacturing run including kitting, material delivery into production suites and other critical duties as needed. This position will directly contribute to the successful delivery of novel cell products in support of human clinical trials.
Execute warehouse and material operations, including material onboarding, material receipt and release, inventory management, kitting operations and material reconciliation
Follow Standard Operating Procedures (SOPs) in compliance with Current Good Manufacturing Practices (cGMP).
Provide support in classified spaces during execution of operations for manufacturing of patient therapies according to SOPs and cGMP, regulatory and safety requirements.
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
Minimum Requirements/Qualifications:
Education and Experience:
For Senior Specialist: Bachelors degree in biotechnology, biology, chemistry, pharmacy, engineering or related pharmaceutical science and 4+ years relevant industry experience or Masters degree in biotechnology, biology, chemistry, pharmacy, engineering or related pharmaceutical science and 2+ years relevant industry experience.
Solid knowledge of cGxP regulations.
Basic knowledge of warehouse operations and material handling.
Ability to work weekends to support on-going manufacturing runs.
Ability to obtain and maintain qualified gowning status.
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/
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 Summary
We 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:
Cambridge, MA
U.S. Base Salary Range:
$86,500.00 - $135,960.00
The 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 Statement
Takeda 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.
Locations
Cambridge, MA
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
Job Exempt
Yes
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
