Director, Product Lifecycle, Parenteral DP MS&T

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The Director of Product Lifecycle Parenteral MS&T is accountable for leading a team of scientists and engineers providing key enabling technical expertise and experimental capabilities for the BMS internal and external commercial parenteral manufacturing network.  This role involves operating our process characterization laboratory to support global tech transfers, critical investigations, and new technology implementation.  Providing product technical leadership and manages our book of work portfolio through our drug product champions and the lifecycle management strategies, including leadership for commercial technical transfer projects and the management of significant DP process changes and continuous improvement projects. This role will routinely interface with Operations (Internal and External), Quality, SS&P, boarder MS&T network, Drug Product Development, and many other colleagues to drive objectives and priorities. The role is also required to provide leadership in the development and execution of Parenteral DP MS&T strategy for the commercial DP portfolio, as well as providing leadership support and technical consultation to Head of Parenteral DP MS&T. A critical deliverable will be to develop and motivate a team of highly capable, experienced SMEs to support objectives of the role in addition to prioritizing available resources, balancing the urgent and the important activities.

This role may involve managing a team across multiple global locations and an ability to travel on an as-needed basis.

Key Job Responsibilities

• Overall technical responsibility for the commercial DP portfolio ensuring continued process performance, including a process for monitoring of trend analysis, and contributing to overall CPV requirements. Constant focus on proactive mitigation of all supply risks, through robustness monitoring and improvement

• Build, develop, and lead a team of engineers and scientists to oversee the Process Characterization laboratory, and provide key technical capabilities, to support global internal and external parenteral manufacturing,

• Provide technical resources to the internal and external Global Manufacturing network to include change control support, process change approval, critical investigations, and other related technical support activities to enable the parenteral sterile manufacturing network.

• Provide technical input/ advisor role into commercial site selection processes and assess both internal and external manufacturing capabilities against current BMS and industry technical standards.

• Provide and mentor project leaders for tech transfer projects when required.

• Develop, implement, and maintain robust processes and tools for managing, prioritizing and communicating to stakeholders on team activities.

• Provide input to Product Development so that new processes are developed in accordance with robustness principles, and with speed to commercialization in mind.

• Lead technical rollout strategies, such as new technology platforms, secondary sourcing, implementation of regulatory technical guidance, business continuity and benchmarking against industry standards

• Manage organization to provide experimental & technical support of new processes and changes throughout the global pharma and biologics parenteral network.

• Proactively ensure that an appropriate technical knowledge level is maintained within the MS&T group, through lesson learned exercises and targeted knowledge acquisition and sharing.

• Reviewer and Designated Accountable Person for sections of the CMC filing (US and ROW) for Parenteral Drug Product MS&T

• Identify product cost drivers and identify opportunities for cost reduction early in produc