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CMC Project Manager - Contract (REF8757Q)

ProPharma Group

CMC Project Manager - Contract (REF8757Q)

Boston, MA
Full Time
Paid
  • Responsibilities

    Job Description

    Our client is seeking a talented Technical Project Manager to play a key role in our Pharmaceutical Sciences function in Boston, MA . The role will report to the Technical Operations (TechOps) Lead, and we are seeking an experienced individual to drive the delivery of pipeline assets and technical projects. The Technical Project Manager will be responsible for Clinical-staged programs and project management functions, which includes all Chemistry, Manufacturing, and Controls (CMC) activities for the client's programs from GLP toxicology through commercial manufacturing and supply. The successful candidate will be results-driven, highly organized, and have a proven track record in managing and driving project success within CMC in the pharma/biotech industry.

    This is a full-time, contract role with a duration of 6-12 months.

    ABOUT THE ROLE:

    • Partner with the TechOps Lead and cross-functional Pharmaceutical Science (PharmSci) team as we manage multiple, complex activities across Drug Substance, Drug Product, Supply Chain, Quality, Analytical and Regulatory CMC.
    • Partner closely with all key stakeholders of Technical Operations team and external CDMOs to develop and maintain integrated project plans to identify/communicate interdependencies as well as critical path activities for the project.
    • Conduct scenario planning and provide analysis and recommendations on development plans and periodically present to TechOps team to ensure alignment.
    • Based on PharmSci strategy, (1) prepare and maintain detailed project timelines and dashboards, (2) track the status of all ongoing development and manufacturing activities and regularly present project status updates,
    • Ensure team members are aware of integrated project timelines and provide timely updates of status and cross-functional impact.
    • Facilitate team meetings using project management best practices/tools to drive cross-functional communication, timely and effective decision making, and successful execution of project objectives.
    • Organize and maintain team communications including meeting agendas, minutes, decision logs, tasks lists, and risk analyses/mitigation strategies. Develop project management tools/templates to facilitate timely communication and execution of projects.
    • Facilitate budgeting/forecasting/long-range planning activities for assigned projects
    • Facilitate with resource and/or manufacturing constraints at CDMOs
  • Qualifications

    Qualifications

    THE IDEAL CANDIDATE WILL HAVE:

    • B.S/M.S. or Ph.D. in Chemistry, Chemical Engineering, Pharmaceutical Engineering, or related discipline with 8+ years of pharmaceutical industry project management experience, and PMP is preferred.
    • Must have exceptional working knowledge of CMC operations
    • Strong Knowledge of Project Management Tools/Software, and demonstrated excellence in project management and effectively managing multiple projects/priorities. Ensures schedules and deliverables are met
    • Working knowledge of pharmaceutical drug development for small molecule drug substances and drug products
    • Ability to manage multiple priorities in fast-paced drug development teams
    • Strategic thinker with good written and verbal communication skills
    • Work with a functional line to develop and manage budget

    Additional Information

    All candidates must be legally eligible to work in the United States.

    We are an equal opportunity employer. M/F/D/V

    ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.