Challenging, Meaningful and Life-changing work awaits at Bristol Myers Squibb. Here, uniquely interesting tasks happen 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.
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.
Job Summary
The Manager, Senior Engineer I role supports 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.
* 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.
* Supporting development and lifecycle management of MBR, MES, and/or eBR, including creation/revision of documentation required to support the production of personalized cell therapy products.
About the Role
* 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.
* 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% 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.
About Us
At Bristol Myers Squibb, we believe that everyone deserves access to innovative medicines that can help them achieve better health outcomes. Our mission is to transform the lives of patients, and the careers of those who work here, through our shared values of passion, innovation, urgency, accountability, inclusion, and integrity.
On-site Protocol
Bristol Myers Squibb has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles, the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
We are committed to diversity and inclusion, and we welcome applications from qualified candidates with arrest and conviction records, pursuant to applicable laws in your area. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.