Senior Process Engineer - Manufacturing Sciences and Tech Operations

Position: Senior Process Engineer – CAR-T Global External Manufacturing Sci and Tech

Location: Flexible: Seattle, WA / Warren, NJ

Position Summary

The CAR-T Global External Manufacturing Science and Technology Senior Process Engineer role is designed to support complex and technical aspects of CAR-T therapy manufacturing operations at external contract manufacturing organization (CMO) sites outside of the US. This role will have responsibilities in a wide variety of projects and tasks involving implementation of new technologies at CMO sites, process improvement initiatives, product and process changes at CMO sites, as well as capacity expansion or technology transfer projects. It is also designed to support routine manufacturing operations including supporting complex manufacturing deviations, change impact evaluations, technical documentation review and approvals, process monitoring, and continuous process verification. This role will require close collaboration with GMSAT team members in Seattle and New Jersey as well as the virtual plant team members and the CMO.

Key Responsibilities

• Support process and technology transfers, change management, and provide technical process support for routine clinical and commercial cell therapy products at the CMO.
• Support strategic initiatives including tech transfers, process validation, technical reports, product comparability and second line support of technical/scientific process and analytical issues.
• Provide remote technical troubleshooting support for manufacturing activities at external manufacturing locations when needed.
• Assist with creation and revision of technical documentation (e.g. changes controls, SOPs, and batch records)
• Assist with validation and startup activities that may include providing process training to support implementation of new technologies and specifications as well as process changes.
• Assist with deviation investigations and corrective and preventive actions (CAPA) as a technical resource. Author technically challenging deviations and drive them towards closure.
• Implement and support the execution of process control strategies including execution of process risk assessments, and continued process verification.
• Support production related investigations, ensuring compliance with internal standards and regulatory requirements
• Perform monitoring of manufacturing processes to understand process capability.
• Leverage and maintain strong relationships with matrixed, cross functional teams and external partners
• Support new product implementations in coordination with Development, Manufacturing, and Quality groups, including visits to contract manufacturing sites
• Support relevant sections of regulatory submissions, permanent inspection readiness activities, and support regulatory inspections
• Ensure manufacturing processes are in a state of control, harmonized across the cell therapy manufacturing network
• Develop, execute manufacturing process improvement activities in accordance with the overall life cycle plan for the product

• Deliver communications tailored to the needs of the receiver (managers, peers, customers) with appropriate frequency to maximize its utility and promote cross-functional collaboration.
• Foster innovative behaviors and strong inter-team relationships to achieve improvement goals.
• Complete regular assignments with minimum supervision.
• Participate in internal learning and sharing events. Participate in external learning and training events related to Cell and Gene Therapy industry and related manufacturing topics.

Qualifications & Experience

Candidates must be comfortable and well-versed working in an online computer-based environment, as work can be performed remotely across time zones. Onsite presence is required at either Seattle or New Jersey BMS office locations with up to 50% remote work from allowed with direct manager approval.

• B.S. with 2-4 years of relevant experience in Biochemical, Chemical, or Biomedical Engineering or Cell Biology/Immunology discipline
• Experience in regulated GMP manufacturing environments
• Flexibility to work within regional manufacturing schedules.
• Work is flexible between on-site and remove work.
• Strong interpersonal and leadership skills to work with teams in different functions and organizations
• Experience or knowledge of statistical analysis using statistical software package. Examples include jmp, Minitab, R
• Technical writing skills with ability to author peer reviewed protocols and reports, production batch records, standard operating procedures
• Ability to complete projects and tasks in partially remote setting without face-to-face supervision
• Ability to function effectively in a structured and regulated work environment by navigating and complying with Standard Operating procedures and quality management processes.
• Demonstrated proficiency with effective and proactive written and verbal communication appropriate for technical and regulated work environment
• Excellent organization skills and ability to multi-task
• Ability to travel domestically and internationally
• Hands-on experience with single-use technologies, closed systems, and cold chain/cryogenic technologies preferred
• Experience with CAR-T therapies strongly preferred

The starting compensation for this job is a range from $87,000 –$110,000, plus incentive cash and stock opportunities (based on eligibility). The starting pay takes into account characteristics of the job, such as required skills and where the job is performed.

Final, individual compensation is decided based on demonstrated experience. For more on benefits, please visit our BMS Careers site. Eligibility for specific benefits listed in our careers site may vary based on the job and location.

Why You Should Apply

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or any part of the recruitment process direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

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