Senior Manager, Automated Manufacturing Implementation

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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 Senior Manger, Automated Manufacturing Implementation is responsible for supporting the design, development, and validation strategy for the Automated Manufacturing Suite (AMS) at Devens CTF, which requires extensive optimization of automated manufacturing process workflows. This role will lead the definition of the physical workflows for the manufacturing process and ensure integration with digital workflows, ensuring seamless and efficient manufacturing operations. The role involves collaboration with cross-functional teams to ensure that design, engineering, and validation are integrated into the overall AMS system and are adaptable to future changes and/or improvements.

Responsibilities:

• Support overall design, engineering and validation of AMS as representative of Devens site operations, ensuring compliance with regulatory and industry standards.
• Lead development and implementation of efficient manufacturing workflows to support AMS operations at Devens.
• Support development of digital workflows, including within DeltaV and MES, to ensure system designs meet operational needs.
• Work collaboratively with Manufacturing, Digital Plant, IT, Validation, Quality, and MSAT to ensure system design meets current needs while also being prepared for future growth and change.
• Own and support risk assessments for AMS project.
• Process and equipment FMEAs, including development of workflows to address potential failures
• Environmental monitoring and cleaning assessments
• Chain of identity and chain of custody
• Troubleshoot and resolve issues related to AMS operations, engineering, and validation processes, including during FAT and SAT.
• Build trust and effective relationships with peers and stakeholders, within CTF Devens and throughout the BMS network.
• Promote a mindset of continuous improvement, problem-solving, and incident prevention.
• The role may evolve to include supervision of staff and contractors involved in design, engineering, and validation of AMS and robotic systems.

Knowledge & Skills:

• Strong understanding of regulatory requirements, industry standards, and best practices for validation in pharmaceutical or biotechnology industries.
• Strong project management, communication, and collaboration skills, with the ability to work effectively in cross-functional teams.
• Experience with equipment startup and validation.
• Experience with single-use technologies and closed systems.
• Experience within a cGMP manufacturing environment, including use of electronic records, electronic control systems, and ERP systems, such as Syncade MES, DeltaV, and SAP.
• Proven ability to develop and execute design, engineering, and validation strategies, including risk assessments, plans, protocols, and reports.
• Excellent problem-solving skills and attention to detail.

Requirements:

• Bachelor’s degree in Science or Engineering, or a related discipline.
• 8+ years of relevant work experience required, preferable within pharmaceutical or biotechnology manufacturing facility subject to cGMP regulations.
• Experience in cell therapy, biologics, or v