Transforming Patients' Lives through Science
At Bristol Myers Squibb, we reimagine the future of Cell Therapy. Our bold ambition, backed by a best-in-the-industry team and long-term commitment, enables us to unlock the full promise of Cell Therapy as we strive to put more patients on the path to a cure.
We are seeking a highly skilled Manager, Senior Engineer I to support the production of personalized cell therapy products at Contract Manufacturing Organizations (CMOs) for both global clinical trials and commercial supply in collaboration with the US-based External Manufacturing GMSAT team.
This role involves providing day-to-day manufacturing support, leading manufacturing investigations pertaining to the process control strategy and associated elements, managing multidisciplinary projects aimed at improving the process and/or drug product life cycle sustainability, managing CPV and process monitoring program, and supporting development and lifecycle management of MBR, MES, and/or eBR.
The Manager, Senior Engineer I will work cross-functionally with subject matter experts from the Development Group, Manufacturing Group, Supply Chain Group, and Quality group to ensure technical support is delivered to a rapidly growing CAR-T manufacturing organization.
Key Responsibilities:
* Function as technology and process SME.
* Provide on the floor or remote real-time troubleshooting and technical process support for ongoing manufacturing activities when needed.
* Lead deviation investigations utilizing root cause analysis tools and identify appropriate Corrective and Preventative Actions (CAPAs), ensuring compliance with internal standards and regulatory requirements.
* Author product impact assessments to support investigations.
* Review and approve manufacturing batch records, change controls, and deviations authored by the CMO.
* Execute process change implementation at CMO in accordance with the overall lifecycle plan for the product.
* Support change initiatives by working with technical and quality teams at CMO to evaluate and implement process improvements.
* Ensure the manufacturing process is in a state of control through the understanding of Continued Process Verification (CPV) data.
* Perform and support data monitoring of manufacturing processes to understand process capability, resolve production issues, and troubleshoot investigation-driven events.
* Author risk assessments, study protocols, and technical reports and revise process documents as needed to support technology transfer and process changes.
* Assist with revisions of the content of technical documentation (e.g. investigations, changes, SOPs and batch records).
* Leverage and maintain strong relationships with CMOs and their vendors, peers, and stakeholders.
* Support health authority and/or internal inspections.
* Interact with other teams including Technical Product Team, Validation, Development, Operations, QA and Regulatory.
* Participate on project teams to help prepare project schedules, execute technical projects and develop presentations to disseminate results to project stakeholders and senior management.
* This position requires up to 10% of travel.
Qualifications & Experience:
* Bachelor's Degree in science or engineering.
* Eight (8) or more years of manufacturing support or related experience in the biopharmaceutical industry.
* Mastery of SOPs and cGMPs and the know-how to work and manage within a regulatory environment.
* Experience with Lean Six Sigma projects, Cellular therapies, process validation, in-depth manufacturing systems is strongly preferred.
* Experience with regulatory agency inspections and regulatory responses is a plus.
* Demonstrated ability to effectively work in cross-functional teams, meet deadlines, and prioritize multiple projects.
* Knowledge of cGMPs and multi-national biopharmaceutical regulations. Cell therapy experience is a major plus.
* Excellent problem-solving skills.
* Hands-on experience with single-use technologies, closed systems, and cold chain/cryogenic technologies.