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Principal Primary Packaging Engineer

Company: Bristol-Myers Squibb
Location: New Brunswick
Posted on: August 14, 2019

Job Description:

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis. Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results. This position provides global technical stewardship of primary container closure systems for the BMS portfolio of commercial biologic 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, syringes, cartridges, etc. 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. SUMMARY: This position provides global technical stewardship of primary container closure systems for the BMS portfolio of commercial biologic 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, syringes, cartridges, etc. 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. MAJOR DUTIES AND 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 design requirements, and support new primary container closure systems selection in early development/clinical phase programs. - Develop and transfer primary container specifications and incoming test methods for commercial parenteral products and ensure the primary container systems meet secondary packaging, shipping, and cold chain requirements. - Lead technical workstreams for lifecycle management of commercial products, including but not limited to: supplier management, risk analysis, component and process improvements. - 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 engineering studies, design verification protocols, stability studies and validation protocols, ensuring appropriate selection of acceptance criteria and sampling plans. Ensures measurement systems analysis (MSAs) for all finished product performance test methods as needed in tech transfer or lifecycle. - 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. - Support site investigations, lead center led investigations, and product complaint trends related to primary components. This includes forensic analysis of complaints, understanding useage, 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 - Support primary packaging related regulatory filings pre and post approval - Support 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. - Collaborate cross-functionally to promote awareness and ensure compliance to new regulatory policies, regulations, directives, and other issues that primary packaging systems. - 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 Material Science, Mechanical Engineering or relevant engineering discipline. Advanced degree a plus. Experience / Knowledge Desired: - Minimum 8 years work experience with Bachelors degree, 6 years with advanced degree in the Medical Device, Pharmaceutical or Biotechnology industry - 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. - Existing technical history working with primary component suppliers for parenteral drug product. - 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 - 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 required - Manufacturing Experience a plus 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 the resources to pursue their goals, both at work and in their personal lives.

Keywords: Bristol-Myers Squibb, New Brunswick , Principal Primary Packaging Engineer, Engineering , New Brunswick, New Jersey

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