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.
MS&T is a science-driven organization dedicated to building in-depth and comprehensive knowledge of our products and their processes.We work across the entire lifecycle of our Pharmaceutical Products and across both internal and external manufacturing/packaging and API Manufacturing.
This position leads and/or manages global and strategic (or technically complex) projects for Bristol-Myers Squibb Global Commercial Supply and ensures projects are delivered within agreed timelines, cost and quality targets. Transfers product knowledge into the Global Commercial Supply organization. Provides technical expertise and support to Packaging Operations to improve capacity, quality, cost or to establish root cause. The success of this function requires effective collaboration with Pharmaceutical Development, Contract Manufacturing, Supply Chain, Manufacturing, Packaging Operations, and Regulatory CMC. Responsibilities will include, but are not limited to the following:
Skills/Knowledge Required :
- Manage strategic packaging projects (such as the Technology Transfer of a product from Development) from project initiation to closure including after action reviews.
- Advocate best practice project methodologies and tools. Develop, write and review project documentation including project plans, test protocols, risk assessments and reports.
- In collaboration with the responsible Product Steward provide technical/scientific expertise and support to packaging sites.
- In collaboration with the Technology Leader Packaging, support product, technology or packaging improvements/changes.
- Assist with writing and reviewing of CMC documentation associated with project or packaging changes.
- Transfer reliable and well understood packaging processes into Global Supply or within the network. Transfer the knowledge from the sending unit to receiving unit and Product Steward. Ensure knowledge is captured and transferred.
- Engage with Packaging sites/Development and CRO/CMO's and advocate the use of scientifically sound principles. Advise on the definition of CQA's and CPP's and an appropriate control strategy.
- Participation in the design, execution and data analysis associated to technical trials/batches associated with the projects. Writing and reviewing project documentation including project plans, test protocols, risk assessments and reports.
- Update a scientific knowledge base. Advises on Scientific and Business developments (including Technology, Processes, Regulations etc).
- Applies and advocates the use of Lean and 6 Sigma methodologies.
- Assist with the development of Standards, guidelines and SOP's to enhance the quality and robustness of our manufacturing operations, knowledge transfer and technical support processes.
- Minimum Bachelor's Degree in Packaging Engineering/Technology, Packaging Development, or similar education in this field.
- At least 8 years of experience in the Pharmaceutical/Cosmetics/Food industry.
- Experience in the development/application of packaging design and their implementation.
- Knowledge and experience of primary, secondary, and tertiary packaging materials.
- Good working knowledge of QA, cGMP and the Pharmaceutical Regulatory framework
- Good knowledge of various types pharmaceutical packaging processes/technologies.
- Good knowledge of Technology Transfer and validation.
- Demonstrated project leadership/management experience. Experience of multi-site/cross-site project management.
- Working knowledge Lean and 6 Sigma methodologies.
- Good leadership skills and ability to influence and work across organizational boundaries.
- Effective communication skills, good command of English and preferably another European language.
- Ability to work well as an integral part of a large Project Team.
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.