Bristol-Myers Squibb
Manager, CMC Project Operations
Bristol-Myers Squibb, New Brunswick, New Jersey, us, 08933
Manager, CMC Project OperationsWorking with UsChallenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
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 with the resources to pursue their goals, both at work and in their personal lives.
PD Portfolio Strategy & Integration (PSI)
Our Portfolio Strategy and Integration team is dedicated to developing and executing CMC strategies for small molecule and biologics portfolio utilizing the brightest minds and ideas across the enterprise to drive strategic choices for Global Product Development and Supply. From candidate selection to commercial launch and life cycle management, we provide valuable project information and portfolio insights, and we lead CMC due diligence for business development opportunities. Joining PSI means you'll have the opportunity to grow and thrive through vast and diverse opportunities.
The CMC Project Manager is closely partnered with the CMC Leader to enable effective execution of CMC strategy and plans. The scope of responsibilities of the CMC Project Manager fall into 4 general categories which flex across all drug modalities, disease areas and stages of development.
Cross-functional CMC Project Management to ensure integrated execution of CMC strategy and communication
CMC Project Timeline Management and timeline scenario planning
Gaps Analysis and Risks Management
Allocation of drug substance and API materials for non-clinical use
Primary Responsibilities:
In partnership with CMC Team Leader, manage 3-5 CMC program assignments (actual number determined by level of project complexity and candidate experience) and drive execution of integrated program strategy
Develop detailed CMC project plan that is aligned with the overall program strategy. Work collaboratively with the CMC team leaders and functions to track all project milestones
Facilitate pertinent CMC scenario planning to address changing business/clinic needs. Gather stakeholder input, evaluate, collate, manage and communicate implications and adjustments to the overall plan
Manage all CMC meeting logistics including the creation of clear, concise minutes
Partner with the CMC Leader to facilitate the management and communication of program risks and mitigation strategies
Leverage portfolio and program management tools to track program execution, milestones, risks, and long range planning to ensure appropriate communication to team members and management.
Coordinate and ensure appropriate allocation of DS and API materials for non-clinical use
The CMC Project Manager may: Co-lead and/or contribute to Product Development portfolio level activities including business process improvement initiatives and resource/budgeting activities, as needed
Experience / Qualifications:
Bachelor's degree in engineering or relevant scientific discipline with at least 5 years of relevant experience / Masters’ degree with a minimum of 2-6 years of relevant experience
Highly motivated self-starter that works well both in teams as well as independently
Strong project management, business process management, and optimization skills
Familiarity with end-to-end CMC drug development with an understanding of critical milestones and typical bottlenecks preferred
Strong organizational skills, ability to multi-task and work in a dynamic, fast paced environment.
Demonstrated ability to accomplish results and meet deadlines and commitments
Strong interpersonal and communications skills, both oral a written
Demonstrated proficiency in MS Project, PowerPoint, Excel and Word
Demonstrated ability to build relationships, influence, negotiate, and drive organizational engagement
Experience developing and/or managing program management tools to forecast budgets, timelines and resources preferred
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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 with the resources to pursue their goals, both at work and in their personal lives.
PD Portfolio Strategy & Integration (PSI)
Our Portfolio Strategy and Integration team is dedicated to developing and executing CMC strategies for small molecule and biologics portfolio utilizing the brightest minds and ideas across the enterprise to drive strategic choices for Global Product Development and Supply. From candidate selection to commercial launch and life cycle management, we provide valuable project information and portfolio insights, and we lead CMC due diligence for business development opportunities. Joining PSI means you'll have the opportunity to grow and thrive through vast and diverse opportunities.
The CMC Project Manager is closely partnered with the CMC Leader to enable effective execution of CMC strategy and plans. The scope of responsibilities of the CMC Project Manager fall into 4 general categories which flex across all drug modalities, disease areas and stages of development.
Cross-functional CMC Project Management to ensure integrated execution of CMC strategy and communication
CMC Project Timeline Management and timeline scenario planning
Gaps Analysis and Risks Management
Allocation of drug substance and API materials for non-clinical use
Primary Responsibilities:
In partnership with CMC Team Leader, manage 3-5 CMC program assignments (actual number determined by level of project complexity and candidate experience) and drive execution of integrated program strategy
Develop detailed CMC project plan that is aligned with the overall program strategy. Work collaboratively with the CMC team leaders and functions to track all project milestones
Facilitate pertinent CMC scenario planning to address changing business/clinic needs. Gather stakeholder input, evaluate, collate, manage and communicate implications and adjustments to the overall plan
Manage all CMC meeting logistics including the creation of clear, concise minutes
Partner with the CMC Leader to facilitate the management and communication of program risks and mitigation strategies
Leverage portfolio and program management tools to track program execution, milestones, risks, and long range planning to ensure appropriate communication to team members and management.
Coordinate and ensure appropriate allocation of DS and API materials for non-clinical use
The CMC Project Manager may: Co-lead and/or contribute to Product Development portfolio level activities including business process improvement initiatives and resource/budgeting activities, as needed
Experience / Qualifications:
Bachelor's degree in engineering or relevant scientific discipline with at least 5 years of relevant experience / Masters’ degree with a minimum of 2-6 years of relevant experience
Highly motivated self-starter that works well both in teams as well as independently
Strong project management, business process management, and optimization skills
Familiarity with end-to-end CMC drug development with an understanding of critical milestones and typical bottlenecks preferred
Strong organizational skills, ability to multi-task and work in a dynamic, fast paced environment.
Demonstrated ability to accomplish results and meet deadlines and commitments
Strong interpersonal and communications skills, both oral a written
Demonstrated proficiency in MS Project, PowerPoint, Excel and Word
Demonstrated ability to build relationships, influence, negotiate, and drive organizational engagement
Experience developing and/or managing program management tools to forecast budgets, timelines and resources preferred
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