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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.

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: careers.bms.com/working-with-us.

This position provides global technical stewardship of our testing network of finished goods and components for the BMS portfolio of commercial drug-device combination products. This position is accountable for the technical interface with internal and external testing labs and manufacturing sites to enable efficient validation, transfer and investigation support for commercial drug-device combination products. This individual has technical ownership of incoming inspection methods and finished goods methods for parenteral combination product during transfer from development to commercial and throughout the commercial product lifecycle at BMS.

Key Responsibilities:

• Collaborate with primary container development, device development, marketing, supply chain, procurement, logistics, internal and external manufacturing sites, to successfully develop, tech transfer and launch packaged products for US and export markets that are in compliance with Design Controls, and relevant elements of the Quality System Regulations

• Work with product development functions and manufacturing sites to establish test methods, and support device-integral combination products in development/clinical phase and commercialization phase.

• Lead technical workstreams for lifecycle management of commercial device and combination products, including but not limited to: change controls, technical investigations, technology transfer, supplier management, risk analysis, component and process improvements.

• Collaborate with supply chain, procurement, logistics, and internal manufacturing sites, to successfully maintain device and combination products.

• Support sites globally to resolve significant quality events and manage complex change controls. Evaluate changes (component, product, process) post design transfer to assess risk/impact on manufacturing process, documentation and design control elements.  

• Work with cross-functional teams to assist in the development of test equipment user requirements specifications, factory acceptance testing protocols and reports, measurement systems analysis protocols and reports, engineering studies, design verification protocols, and stability studies, ensuring appropriate selection of acceptance criteria and sampling plans.

• Participate in design reviews and provide SME input.  Review supporting documentation, approving documents as part of tech transfer, and ensure those documents are suitable to minimize risk to commercial manufacturing, supply, and patients. 

• Employs project management practices for developing project timelines, resources, monitoring progress and project status communication.

• Lead and/or support global or site investigations related to atypical testing results.  This includes investigations into incoming inspection or release testing atypical results.  Experience required using engineering tools to determine root cause and ensure components and materials meet BMS performance and quality standards.

• Support primary packaging, device and combination product related regulatory filings pre and post approval.

• Actively participate in an internal and external network of experts, and industry forums, to keep the organization at the forefront of primary packaging technology and innovation.

• Responsibilities also include mentoring and developing other members of the Device & Packaging Technology team in primary packaging as well as cross training to expand knowledge in other disciplines within the group.

KNOWLEDGE / SKILL:

​Education:

• BS degree in Mechanical Engineering, Biomedical Engineering, Material Engineering, or relevant engineering discipline.  Advanced degree a plus.

Experience / Knowledge Desired:

• Minimum 10 years' work experience with bachelor’s degree, 6 years with advanced degree in the Medical Device, Pharmaceutical or Biotechnology industry

• Experience with medical device visual inspection techniques and functional testing preferred.

• Existing technical history working with testing equipment suppliers a plus.

• Expert in drug-delivery medical device and combination products design and/or manufacture. Prior experience with prefilled syringe or autoinjector a plus.

• Thorough knowledge of design control and quality systems regulations (21 CFR 820 & 211, ISO 13485) related to medical device and combination products.

• Strong analytical, technical writing, interpersonal, and communication skills with ability to present internally/ externally to suppliers, sites, health authorities, and Sr. Management.

• Demonstrated ability to: 1) influence areas not under direct control to achieve objectives.2) manage multiple programs and create a high-performance work environment. 3)work in a matrix environment and effectively support internal & external manufacturers and suppliers.4) build alignment with business partners and key stakeholders. 5)manage risk and make rapid decisions.

• Working competency of statistical programs (i.e., Minitab, SAS, etc.)

• Certified Six Sigma Green/Black belt or equivalent preferred.

• Product Development Experience preferred.

• Manufacturing Experience a plus

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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 science™ ”, 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 [email protected]. Visit careers.bms.com/eeo-accessibility 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.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

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