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Job Description

Job Title: Sr Cell Bank Engineer II

Location: Lexington, MA

About the role:

As an important member of the global Cell Bank Center of Excellence, you will report to the head of cell bank global center and provide technical and scientific leadership in the development, manufacture, and testing of new and improved processes for internal clinical or commercial GMP Cell Banks. You will help to support production operations, monitoring of process performance, supporting containment of process failures or quality deviations that may result during operations, and help implement associated corrective and preventative actions.

You are expected to partner with members of other technical functions (e.g. Cell Line Development, Upstream Pharmaceutical Sciences, and Global Manufacturing Sciences, Global Quality, Regulatory, Supply Chain) to independently develop laboratory studies that are geared at improving cell banking operations which eliminate waste, improve efficiency, and improve process performance/robustness.

How you will contribute:

• Provide regular hands-on support for cell banking manufacturing operations
• Independently design and accomplish laboratory studies focused on resolution to cell banking technical issues.
• Represent Cell Bank Center of Excellence, on technology transfers and strategic initiatives. Provide leadership to ensure success of project/initiative.
• Provide technical support for Change Control activities and manage changes independently
• Generate proposals, protocols and reports, and present data at internal meetings.
• Support regulatory inspections and filings as an author and reviewer.
• Provide high quality written study proposals, research and development reports, and investigation reports
• Develop rationale, business case, and technical justification for improvements to clinical and/or commercial cell bank processes
• May mentor junior staff
• Be a resource/SME for staff and improvement projects
• Provide documentation for proposals, protocols, reports and risk assessments
• Provide support for investigations and work with cross-functional teams to identify most probable root cause and subsequent corrective/preventive actions
• Implement assigned actions in support of deviations, audit responses, and corrective actions to meet established timelines
• Participate in facility and process inspections with domestic and/or international regulatory agencies

What you bring to Takeda:

• B.S. in Cell or Molecular Biology, Biochemistry, Biochemical Engineering (or related field) with 8-12 years of industry experience or M.S. with 6 – 10 years of relevant industry experience.
• Expertise with mammalian cell culture, recombinant proteins, and cell cryopreservation (master and working cell banks) in a cGMP manufacturing environment is desired.
• Demonstrated skills in cell & molecular biology
• Knowledge of emerging technologies, regulatory landscape, and a strong desire to employ a continuous improvement approach to operations
• Ability to author technical reports and comfort utilizing electronic documentation workflows for review, approval, and archival
• Demonstrates appropriate level of adaptability, maintains positive outlook, and demonstrates composure under pressure.
• Flexibility to work according to the production schedule.

Important Considerations

At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may:

• Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
• Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
• Work in a cold, wet environment.
• Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.
• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
• The candidate will be required to carry a cellular device and may be expected to support meetings across global time zones.

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.

#GMSGQ #ZR1 #LI-MA1

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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