Senior Cell Bank Engineer II

Takeda

  • Lexington, MA
  • Permanent
  • Full-time
  • 1 month ago
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 and . I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionJob Title: Sr Cell Bank Engineer IILocation: Lexington, MAAbout 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.
Key Skills, Abilities, and Competencies
  • 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.
Other Job RequirementsThe candidate will be required to carry a cellular device and may be expected to support meetings across global time zones.What Takeda can offer you:
  • Comprehensive Healthcare: Medical, Dental, and Vision
  • Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
  • Health & Wellness programs including onsite flu shots and health screenings
  • Generous time off for vacation and the option to purchase additional vacation days
  • Community Outreach Programs and company match of charitable contributions
  • Family Planning Support
  • Professional training and development opportunities
  • Tuition reimbursement
Important ConsiderationsAt 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.
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.This posting excludes Colorado applicants.#GMSGQ #ZR1 #LI-MA1EEO 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.LocationsUSA - MA - Lexington - BIO OPSWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time

Takeda