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Manager, Senior Engineer I
vor 3 Monaten
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.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more:
Title: Manager, Senior Engineer I
Location: Boudry, Switzerland
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) support 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 andcGMPs 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.
BMSCART
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as "Transforming patients' lives through scienceTM ", every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol
BMS 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.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to Visit to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants 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.
