US-MA, Senior Cell Bank Technical Operations Scientist SR0032752-MZ
With minimal supervision this self-motivated individual will deliver leadership and excellence in
manufacturing processing, leading/or supporting technical transfer of projects to meet GMP Cell Bank
production for clinical and commercial programs. A key area of responsibility will include the identification
and implementation of technologies to ensure alignment of cell culture processes from Development to
Cell Banking to Biologics Manufacturing and ensuring execution of method transfers related to cell banking
across the global network. The incumbent will also have responsibilities in supporting site selection and
interacting with External Site Operations group for management of external CMO cell banking projects.
The successful candidate is expected to author technical documentation and justifications for new process
The individual is expected to provide technical support through interactions with support groups to ensure
accurate and well managed transfer of process changes/improvements to floor operations. Provide
support to integrate best practices, where appropriate, into manufacturing as part of the Global Cell Bank
Network. Cross functional collaboration is a must
Expertise with mammalian cell culture and cell cryopreservation (master and working cell banks) in a
cGMP manufacturing environment is highly desirable.
Lead or support technology transfers by coordinating team activities and providing schedules, technical knowledge and documentation for new manufacturing processes and other portfolio projects (e.g. Capital projects).
Design/conduct laboratory studies aimed at Cell Bank method transfer support for storage stability studies, and other laboratory studies aimed at increasing cell culture process knowledge and improving process robustness
Identify, recommend/Implement process changes/improvements, efficiency gains or safety/ergonomic improvements. Enhance established processes and to be in step with industry practices.
Identification and implementation of technologies to ensure alignment of cell culture processes from Development to Cell Banking to Biologics Manufacturing.
Assemble and analyze manufacturing data aimed at both long-term trending and resolution of investigations. Collaborate closely, provide hands-on support as necessary and provide input to other departments e.g. manufacturing, PDTS, QC lab as required.
Support Change Control activities Collaborate with Materials Management to ensure raw material planning and release for timed use in manufacturing. Generate proposals, protocols and reports, and present data internal meetings.
Act as the lead on on-the-floor technical issues and provide risk assessments if required.
Contact for troubleshooting and issue resolution or escalation.
Ensure work is carried out in a safe manner, notifying management of safety issues and risks. Stays current with biotechnology industry best practices.
Act as a role model (Lead by Example)
Provide timely feedback on staff s performance
Act as a resource/SME for staff and improvement projects
Ensure the use of safe work practices and behaviors
Lead/Support Tier 1 board communications and Tier 2 as required and suggest Continuous Improvements
Review and write SOPs, as needed, to support GMP manufacturing
Collaborate across departments at site and globally in support of network Cell Banking.
Provide documentation for proposals, protocols, reports and risk assessments
Initiate deviations or investigations and work with cross-functional departments to identify root cause or reach closure
Implement appropriate corrective actions
Complete action items for GMP investigations, audit responses and CAPA s in accordance to established timeline
Communicate any quality issues/concerns to Supervisor and QA
Participate in facility and process inspections by domestic and international regulatory agencies.
Education and Experience Requirements
Master s of science with 4 or Bachelor s of Science degree and 6 years or PhD with 0-1 years of relevant industry experience or an equivalent level of education and/or related experience is acceptable. Experience in Cell Banking operations is a plus.
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Equal Employment Opportunity
Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
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