Principal Scientist, Primary Packaging - Parenteral MS&T

Working with Us
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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 w