Manager, Senior Engineer I
Vor 2 Tagen
Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
At Bristol Myers Squibb we are reimagining the future of Cell Therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of Cell Therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here at BMS with our Cell Therapy team.
The Manager, Senior Engineer I role is responsible for supporting 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.
Potential areas of responsibility include (a) providing day-to-day manufacturing support, (b) leading manufacturing investigations pertaining to the process control strategy and associated elements, (c) managing multidisciplinary projects aimed at improving the process and/or drug product life cycle sustainability, (d) managing CPV and process monitoring program, and (e) supporting development and lifecycle management of MBR, MES, and/or eBR. These areas include creation/revision of documentation (i.e. SOP, change control, validation documentation, technical reports, etc.) required to support the production of personalized cell therapy products.
Cross-functional collaboration with subject matter experts (SMEs) from the Development Group, Manufacturing Group, Supply Chain Group, and Quality group is essential to ensuring 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.
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