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Sr CMC Project Manager
Portfolio Strategy and Integration
Posted on 8/24/2022
Summit, NJ, USA
Experience Level
Desired Skills
  • Bachelor's degree in engineering or relevant scientific discipline with at least 5 years of relevant
  • Experience, Masters' degree or PhD with a minimum of 3-5 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 analytical and logic skills with a focus on fact-based decision making
  • 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
  • CMC Management, including meeting planning, facilitation and documentation
  • CMC Project Timeline Management, including maintenance of up-to-date MS project timelines and timeline scenario planning
  • Gaps Analysis and Risks Management
  • Allocation of drug substance and API materials for non-clinical use
  • The PM is a leader, coordinator, and facilitator for the Portfolio Strategy and Integration group, providing tactical direction, managing teams, and providing tactical solutions that support the overall program strategy developed by the CMC team
  • Manages 4-6 ICs in the CMC team (number determined by level of project complexity and candidate experience) and drives execution of program strategy by fostering communication and integration of all functional area representatives on the CMC team
  • Drives and manages all CMC meeting logistics including the creation of clear and concise meeting minutes that will be shared as appropriate to align all functional representatives of decisions and actions agreed upon by the team
  • Facilitates sub-team meetings, as appropriate
  • Responsibility for the development of a detailed CMC project plan that is aligned with the overall program strategy. Tracks all project milestones and clearly communicates status of project through the use of established PSI tools
  • Leverages portfolio and program management tools to track program execution, milestones, risks, and long range planning to ensure appropriate communication to team members and management. Examples include the following: PSI CMC Database, OnePager Pro, MS Project Server, DOI Tool, Right First Time Scorecard, Operational Risk Management
  • Work collaboratively with the CMC Leaders and functional leaders to track the critical operational aspects of the program(s), including monitoring key deliverables, decision points, demand planning, and critical path activities to drive delivery of project objectives which roll up to the Product Development BOW. Is responsible for contributing to the definition and execution of risk management strategies, contingency planning, supporting the development of a high performing team(s), and communication of the solutions to management
  • Partner with the CMC Leader to facilitate the management of risk by scheduling meetings with the CMC as appropriate. The Senior CMC Project Manager is responsible for capturing all gaps/risks into the appropriate PSI tools to enable effective portfolio visuals of the gaps and risks
  • Coordinates and ensure appropriate allocation of drug substance and API materials for non-clinical use. The Senior CMC Project Manager may: Lead certain cross-functional sub-team meetings as may be needed
  • Represent the CMC in certain governance interactions, as appropriate Lead and/or participate in Product Development portfolio level activities including business process improvement initiatives and resource/budgeting activities, as needed
Bristol-Myers Squibb

10,001+ employees

Biopharmaceutical development company
Company Overview
Bristol-Myers Squibb engages in the discovery, development, licensing, manufacturing, marketing, distribution and sale of pharmaceuticals.