With minimal supervision this self-motivated individual will deliver leadership and excellence in manufacturing processing, technical transfer of processes and new technologies, as well as hands on operations to meet site demands for cell bank production for clinical and commercial programs in the GMP cell bank manufacturing area. A key area of responsibility will include the identification and implementation of technologies to improve efficiencies, enable new processes and implement platform processes. The successful candidate is expected to author technical documentation and justifications for new process introductions.
The individual is expected to ensure safety, aseptic operations and compliance with cGMPs are maintained at all times. 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 Center of Excellence. 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.
- Responsible for hands on Cell Bank operations on the production floor and troubleshooting to ensure that all operations are in full compliance with applicable MBRs/FPs, SOPs and safety guidelines.
- Identify, recommend/Implement process changes/improvements, efficiency gains or safety/ergonomic improvements. Enhance established processes for efficiency gains and to be in step with industry practices.
- Provide technical instruction on new/improved processes to Manufacturing team
- Support technology transfers by coordinating team activities and providing technical knowledge and documentation for new manufacturing processes.
- Collaborate closely, provide hands-on support and provide input to development
- Ensure alignment of cell bank processes between development up to manufacturing.
- 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 technical issues and provide risk assessments if required.
- Manufacturing data management and statistical analysis of data aimed at process knowledge development/ownership and resolution of investigations.
- Contact for troubleshooting and issue resolution or escalation.
- Execution of routine and critical operations as well as commissioning and validation activities for technology transfer and continuous improvements.
- Ensure work is carried out in a safe manner, notifying management of safety issues and risks.
- Responsible for transfers of processes and new technology into the Cell bank facility and other portfolio projects (e.g. Capital projects).
- Assemble and analyze manufacturing data aimed at both long-term trending and resolution of investigations.
- Stays current with biotechnology industry best practices
- Collaborate and provide hands-on support and input to other departments e.g. PDTS, QC lab as required
- 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 CI.
- Review and write SOPs, as needed, to support GMP manufacturing
- Collaborate across departments at site and globally in support of the network.
- 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
- Revise and author Standard Operating Procedures/Batch Records as required
- 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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