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Senior CMC Project Manager

New Brunswick, NJ

Posted: 09/14/2022 Job Number: 21762106

Job Description

SENIOR CMC PROJECT MANAGER
NEW BRUNSWICK, NJ
New Brunswick, NJ or Summit, NJ. Will be required to be onsite at least 50% of the time - this is a hybrid role.

Project Description:
  • The Senior CMC Project Manager is closely partnered with the CMC Team Leader to enable effective development and execution of integrated CMC strategy and plans.
  • The scope of responsibilities of the Sen. CMC Project Manager falls into 5 general categories which flex across all drug modalities, disease areas and stages of development:
    • Cross-functional CMC team Management, including meeting planning, facilitation, and documentation .
    • Integrated CMC Project Plan Management, including maintenance of up-to-date project timelines and timeline scenario planning Gaps Analysis and Risks Management.
    • Planning and allocation of CMC drug material demand for non-clinical use .
    • Ensure accuracy of PM-related information in established portfolio and program management tools to track program execution, milestones, risks, and long-range planning to ensure appropriate communication to team members and management .
  • CMC PM is a leader, coordinator, and facilitator for the Portfolio Strategy and Integration (PSI) organization, providing tactical direction, managing teams, and providing tactical solutions that support the overall program strategy developed by the Integrated CMC team .
  • CMC PM is expected to manage 4-5 development assets (actual number determined by level of project complexity and candidate experience) and drive execution of program strategy by fostering communication and integration of all functional area representatives on the integrated CMC development team .
  • Establish strong partnership with CMC Team Leader to shape the overall strategy and ensure successful execution of early to late-stage programs in product development portfolio the comprises of small and large molecules .
  • Facilitate cross-functional CMC team meetings using meeting management best practices to drive timely and effective decision-making and successful execution of program objectives .
  • Create and manage all integrated CMC meeting logistics including the creation of clear and concise meeting minutes that are shared as appropriate to align all functional representatives of decisions and actions agreed upon by the team .
  • Responsible for the development of a detailed CMC project plan that is aligned with the overall program strategy .
  • Leverage established 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 of these tolls include (CMC Database, OnePager Pro, MS Project, ePlan/Planisware, DOI Tool, Right First Time Scorecard, Operational Risk Management) .
  • Work collaboratively with the CMC team 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 .
  • 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 team Leader to facilitate the management of risk by scheduling meetings with the CMC teams as appropriate .
  • Coordinate and ensure appropriate allocation of drug substance and API materials for non-clinical use.

Required 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 .
  • 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 .
  • Experience in cross functional project management (preferably CMC) .
  • Familiarity with end-to-end CMC drug development with an understanding of critical milestones and typical bottlenecks .
  • Ability to develop strong collaborative working relationships with stakeholders and across technical functions to drive efficient execution of CMC program strategy .
  • Strong organizational, interpersonal & communication skills, be agile, display an enthusiastic and collaborative attitude with peers and team members .
  • General knowledge of pharmaceutical development (specific CMC Chemistry Manufacturing and Control) starting from Discovery to Commercialization (New Chemical Entity versus a Generic).
  • Experience in the synthesis (Chemist) of the drug substance or formulation development of the drug product (Pharmacist).
  • Project Management (timeline MS Project, ePlan, strategy, meeting management).
  • Matrix Team management (lead by influence).
  • CMC development experience and participation on matrix development teams for New Chemical Entities (NCE).

This 12+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Bridget: bridget@alphaconsulting.Com

ALPHA'S REQUIREMENT #22-02655
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE

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Bridget Burns

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