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Description This position provides global technical stewardship of primary container closure systems for the BMS portfolio of commercial parenteral biologic and small molecule drug products. This position is accountable for the technical interface with product development to enable requirements definition, design and selection of robust primary container systems such as stoppers, vials, and seals for commercial biologic drug product. This individual has technical ownership of global primary packaging systems for parenteral drug product throughout the commercial product lifecycle at BMS. This includes global oversight of specifications for components, performance monitoring within supplier manufacturing processes, and test methods.
Key responsibilities include
- Leads technical workstreams for lifecycle management of commercial products, including but not limited to: supplier management, risk analysis, component and technology improvements.
- Supports sites globally to resolve critical and complex quality events and manage complex change controls. Evaluates changes (component, product, process) post design transfer to assess risk/impact on manufacturing process, documentation and design control elements.
- Supports site investigations, lead center led investigations, and product complaint trends related to primary components. This includes forensic analysis of complaints, understanding usage, conducting Design of Experiments, and application of other engineering tools to determine root cause and ensure components and materials meet BMS performance and quality standards
- Develops and transfer primary container specifications and incoming test methods for late stage development and commercial parenteral products and collaborates with secondary packaging to ensure the primary container systems meet shipping and cold chain requirements.
- Participates 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.
- Supports primary packaging related regulatory filings pre and post approval.
- Supports Manufacturing sites, Procurement, Global Quality and Compliance in supplier, customer, internal, and/or regulatory agency audits and provide technical leadership of supplier robustness, which includes assessments of component manufacturers' supply capability.
- Collaborates cross-functionally to promote awareness and ensure compliance to new regulatory policies, regulations, directives, and other issues related to primary packaging systems. Builds a strong relationship with the combination device organization, including the individuals that work on device primary packaging components.
- Actively participates in an internal and external network of experts, and industry forums, to keep the organization at the forefront of primary packaging technology and next generation option. Represents Bristol Myers Squibb at conferences to contribute innovation sharing.
- Collaborates with primary container development, device development, marketing, supply chain, global procurement, logistics, internal and external manufacturing sites, to successfully develop, tech transfer and launch packaged products
- Works with clinical and manufacturing sites to establish design requirements, and support new primary container closure systems selection in early development/clinical phase programs.
Qualifications
- Bachelor degree with 7 years of relevant experience. Relevant Masters or Ph.D. degrees are preferred (but not required). Time spent in advanced degree program may be considered as equivalent experience.
Key Skills and Experience
- Expert in Biologics/sterile/liquid drug product packaging systems design and/or manufacture.
- Experience with drug product parenteral visual inspection techniques, standards, and forensics with respect to primary container defects preferred.
- Deep scientific understanding of the materials science and technology behind the manufacture and design of primary container systems, with a particular emphasis on glass properties and related defects and elastomer properties and manufacturing processes.
- Demonstrated technical experience working with primary component suppliers for parenteral drug product, particularly with marketed products.
- Thorough knowledge of quality systems, Quality by Design, validation principles for product and manufacturing processes, engineering design and process control fundamentals including primary container analysis.
- Thorough understanding of regulations, familiarity of regulatory environment and industry trends for primary container design and manufacturing.
- 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:
- influence areas not under direct control to achieve objectives
- work strategically, manage multiple programs and create a high performance work environment
- work in a matrix environment and effectively support internal & external manufacturers and suppliers
- build alignment with business partners and key stakeholders
- 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 and manufacturing experience a plus
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 adastaffingsupport@bms.com . 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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