Senior Specialist, Engineer II, External MS&T

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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.

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Title: Senior Specialist, Engineer II, External MS&T

Location: Warren, NJ or Summit, NJ

The Senior Specialist, Engineer II, External MS&T is responsible for supporting the production of personalized cell therapy products for both global clinical and commercial supply for CMOs and collaborate with the US-based Cell Therapy Technical Organization's External MS&T team to lead efforts related to technology transfer and continuous commercial manufacturing of BMS cell therapy products while being based in US. The engineer will support CMOs including creation, changes, and enhancements to process documentation (batch records, work instructions, SOPs, etc.) occurring at CMOs. The person will be responsible 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. This engineer will work closely with a cross-functional team of members from QA and external manufacturing to support all MSAT related activities at CMOs.

Key Responsibilities:

• Provide technical process support for on-going manufacturing, routine clinical and/or commercial cell therapy product.
• Review and approve manufacturing batch records, change controls, and deviations authored by the CMO.
• Review executed batch records to ensure process is operating within the validated state
• Work with technical and quality teams at CMO to evaluate and implement process improvements
• Author risk assessments, study protocols, and technical reports and revise process documents as needed to support technology transfer and process changes
• Perform and support data monitoring of manufacturing processes to understand process capability, resolve production issues and troubleshoot investigation-driven events
• Ensure the manufacturing process is in a state of control, through an understanding of CPV data.
• Support production related investigations, ensuring compliance with internal standards and regulatory requirements.
• Support the change initiatives and the implementation of process improvement initiatives.
• Participate on project teams to help prepare project schedules, execute technical projects and develop presentations to project stakeholders and senior management.
• Leverage and maintain strong relationships with external CMOs and their vendors, peers and stakeholders.
• Support permanent inspection readiness and actively support regulatory inspections.
• Develop, execute manufacturing process improvement activities in accordance with the overall life cycle plan for the product.
• Share operational best practices and process learning with the rest of the manufacturing network.
• This position requires up to 25% of travel

Qualifications & Experience:

• Master’s or Bachelor’s Degree in Chemical Engineering, Biochemical
• Engineering or equivalent with minimum of 1-3 years relevant experience in
• biologic process/analytical development or commercial biologic manufacturing process support.
• Experience with cell culture or aseptic techniques is preferred.
• Experience in a regulated, GMP manufacturing environment is required.
• Experience