Senior Manager, Automated Manufacturing Implementation

Bristol-Myers Squibb-posted 4 months ago

$138,460 - $167,777/Yr

Full-time • Senior

Hybrid • Devens, MA

Chemical Manufacturing

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The Senior Manager, 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.

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.

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 vaccine manufacturing support, tech transfer, and validation is required.
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.

Medical, pharmacy, dental and vision care.
Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP).
Financial well-being resources and a 401(K).
Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support.
Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility.
Parental, caregiver, bereavement, and military leave.
Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources.
Other perks like tuition reimbursement and a recognition program.

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