Specialist, Manufacturing Sciences and Analytical Technologies - Cell Therapies

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Job Description

Specialist,  Manufacturing Sciences and Analytical Technologies - Cell Therapies

Are you looking for a patient-focused company that will inspire you and support your career? If so, you can be empowered to take charge of your future at Takeda. Join us as a Specialist, MSAT, 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 worldwide.

Here, you will be a vital contributor to our inspiring, bold mission.

POSITION OBJECTIVES:

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, focusing on the qualification and optimization of processes 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.

POSITION ACCOUNTABILITIES:

• 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 with the Technical Operation and Quality Team.
• Develop and manage tools and templates that can be used to assess the impact and criticality of parameters and attributes.
• Revise and edit master batch records 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 integrating and implementing digital data enterprises, including electronic Batch Records and data systems.

EDUCATION, EXPERIENCE AND SKILLS:

Education and Experience:

Specialist, MSAT:

• 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.

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.

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U.S. Base Salary Range:

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.

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