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CMC Project Management Lead - Gene Therapy at PTC Therapeutics, Inc.

Posted in Installation - Maint - Repair 30+ days ago.

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Type: Full-Time
Location: Lynnfield, Massachusetts

Job Description:

Job Description Summary:

Job Description:

CMC Project Management Lead – Gene Therapy

The CMC Project Management Lead will have primary responsibility for leading and managing multiple CMC projects. This role coordinates, supports, and assists in all aspects of the cross-functional CMC projects, ensuring each project is defined and executed in a manner consistent with the best project management practices and PTC’s project management governance. This role will report directly to the Executive Director of Technical Operations and will have a close collaboration with PTC’s Project Management Office (PMO).

The CMC Project Management Lead will collaborate with internal personnel and external CMOs/CROs Project Managers in the development of comprehensive timelines. The PM will be responsible for implementation of the CMC strategy and actively monitoring/reporting on performance, highlighting assumptions and unknowns to ensure full transparency to key internal/external stakeholders.

Responsibilities to include, but not limited to

  • Develop and manage integrated CMC timelines across all programs within PTC’s Gene Therapy (GT) pipeline

  • Work closely with CMC Technical Operations to ensure all CMC team deliverables and activities are aligned across other functions, and facilitate communication to ensure clarity and transparency

  • Ensure that CMC timelines and dependencies feed into the overall master project plan

  • Manage triple constraints (Cost, Schedule, Scope/Quality) across all CMC deliverables

  • Working closely and communicating effectively with cross-functional teams and leaders from all parts of PTC GT and CMOs/CROs to ensure the team is set up to successfully deliver on all CMC project commitments, that includes:

    • Coordinate and lead project team teleconferences and meetings with stakeholders, documenting minutes and managing action items

    • Implement the CMC project's strategy

    • Proactively define potential risks and risk management strategies

    • Identify the project objectives and scope

    • Identify measurable success criteria

    • Build a fully integrated schedule capturing all activities needed to deliver PTC GT business objectives

    • Develop and implement stakeholder management and communication plans

  • Apply best practice project management techniques, including

    • Monitor and report progress of team against milestones, deliverables, identification and management of project issues

    • Adjust the project in response to progress, unanticipated delay, and changing business environment

    • Identify project risks and develop appropriate mitigation strategies

  • Facilitate communication across the company, and CMOs/CROs, and engage stakeholders with a solution-oriented focus and present strategies and plans to senior management and governance forums

  • Foster a culture of ownership and accountability including continuous evaluation, recognition, and process improvement

Education/Experience Requirements

    Special knowledge or skills required

    • Proficiency working with project management tools (i.e. MS Project Professional) to manage project scheduling and tracking.

    • Operating skills including the ability to plan and organize the work to marshal resources and get the work done

    • High level of personal and professional integrity and trustworthiness with strong work ethic

    • Strong skills in communication, meeting management, and verbal, written, and presentation skills

    • Strong ability to embrace ambiguity and complexity and demonstrate problem­

    solving leadership; ability to translate complex concepts into actionable, measurable tasks

    • Ability to respond quickly and effectively to changing environments

    • Demonstrated people management skills. Ability to create effective relationships, motivate others, influence without authority, and collaborate internally and externally at all organization levels

    • Skilled facilitator and negotiator with a keen eye for detail

    Special knowledge or skills preferred

    • CMC project management background and understanding of clinical gene therapy drug development process

    • Prior CMO project management experience

    • In-depth knowledge of cGMP requirements for pharmaceutical or biotechnology environment and understanding of biologics manufacturing and/or bioprocess/product/analytical development strongly preferred

    • Record of successful regulatory filings (INDs, BLAs, MAAs)

    EEO Statement:

    PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.

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