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Development Engineer
Ref No.: 18-16800
Location: Lexington, Massachusetts
The individual will be a member within a group responsible for performing upstream process development, including timely completion of small-scale experiments, scale-up, technology transfer and GMP floor support for programs that bring new biopharmaceutical products to pre-clinical, clinical and process validation manufacturing phases. Scope of work includes cell banking, cell expansion, bioreactor process, and harvest clarification process development, optimization, characterization, scale-up, and technology transfer to CMO’s and/or internal manufacturing facilities. The individual applies basic knowledge from various technical areas, industry standards and practices, provides quality and productive output that is consistently timely, reliable and reproducible. The candidate must be customer focused, results oriented, science driven and embrace Shire’s values.

• Provide technical support, apply knowledge, and execute experiments for the development and optimization of cell culture processes. Activities will be in line with overall project plan and milestones under close supervision. Manage, operate, monitor, and troubleshoot a range of bioreactors and related control systems. Interacts with manufacturing operations staff, participates during troubleshooting of issues. Executes IND-and BLA-enabling studies.

• Documents data accurately in laboratory notebooks as per established company guidelines and procedures. Drafts technical reports, memos, procedures, technology transfer packages and presentations.

• Participate in and contribute to team meetings, including sub-teams, project teams, tech. transfer teams, and departmental meetings.