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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.

Join Takeda as a Senior Manager, Cell Therapy Systems and Validation where you will enable implementation of new equipment, technologies, computerized and enterprise systems at a GMP cell therapy clinical manufacturing facility.

You will coordinate with cross functional groups (IT, QA, Manufacturing, Process Development etc.) to validate GXP equipment and systems.

You will serve as site lead for validation efforts and ensure compliance with global Takeda procedures.

How you will contribute:

• Lead and execute validation efforts for the cell therapy clinical manufacturing site including validation of equipment, software and computerized systems.

• Understand development of CSV and equipment specifications and execute Computer System Validation, System Development Life Cycle (SDLC), and other pharmaceutical equipment/system and commissioning/validation (IQ/OQ/PQ) protocols.

• Serve as subject matter expert for new systems and continuing validation, ensuring that all validation activities align with global Takeda procedures.

• Assess the impact of changes to cGMP equipment/systems and methods and establish the applicable Validation Plan to ensure the validated status is maintained

• Contribute to discussions about equipment, software, and system development to ensure that early-stage equipment is suitable for use in a GMP setting.

• Lead continuing qualification of validated systems on the site and contribute to process improvements regarding new system validation and continuing qualification efforts.

Minimum Requirements/Qualifications:

• BS engineering or science degree with 11+ years of experience or an MS engineering or science degree with 9+ years of experience working in the pharmaceutical industry or PhD degree with 3+ years.

• Demonstrated experience in cGMP automation/computerized systems, quality, and compliance areas in the pharmaceutical industry and demonstrated knowledge of equipment, software and computerized system validation.

• Knowledge of GXP data integrity requirements and demonstrated experience implementing compliant systems is required.

• Experience with SDLC, AIQ and CSV processes and implementations is required.

• Strong understanding of Testing and Software Development Lifecycle and QA methodologies.

• Experience working closely with IT function to develop functional, configuration and design specifications.

• Highly developed matrix management skills with demonstrated ability to align, motivate, and empower cross-functional team members.

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:

Boston, MA

U.S. Base Salary Range:

$133,000.00 - $209,000.00

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

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time