Senior Cell Bank Engineer II
Takeda
- Lexington, MA
- Permanent
- Full-time
- 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
- 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.
- 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
- 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.