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Regulatory Project Manager CMC

2 months ago

Trenton, United States System One Full time

Job Title : Regulatory Project Manager CMC

Location : Warren NJ (Hybrid)

Compensation : $80 W2

Type:

Contract

Responsibilities

Primary Responsibilities:

Partner with project, functional, and work stream leads to successfully achieve project objectives inclusive of program assets as well as strategic initiatives.

Apply project management expertise across the portfolio for standard and complex projects, managing one project in detail.

Provide strong team leadership and drive to ensure projects are executed on-time and within budget.

Facilitate the definition of project scope, goals, and deliverables.

Create project plans; scope, work, resources, scheduling, etc.

Maintain project objectives throughout the project lifecycle.

Monitor execution and quality of alliance partner to customer/stakeholder/sponsor standards.

Identify and resolve issues and risks.

Report on project progress, offering viable solutions and opportunities as they arise.

Implement appropriate project change control.

Facilitate all project team meetings; attend related project meetings as necessary to ensure alignment.

Evaluate and assess the results of the project through regular after-action reviews.

Provide structure and leadership across departments to ensure the team meets project objectives.

Work with internal and external stakeholders to manage project deliverables, e.g., CMO’s, Supply Chain, etc.

Develop and communicate status to organizational leadership.

CMC Support and Sub-Team Management Responsibilities:

Lead and coordinate Drug Product Process Development and related CMC sub-teams to ensure alignment with overall project goals and timelines.

Collaborate closely with CMC functional areas, including process development, analytical development, quality, and regulatory, to support project objectives.

Develop and maintain detailed CMC project plans, including resource allocation, risk management, and timeline tracking.

Facilitate cross-functional CMC sub-team meetings to ensure alignment and address any CMC-related issues or risks.

Monitor and report on the progress of Drug Product Process Development activities, ensuring that all milestones are met and any deviations are promptly addressed.

Ensure clear communication and collaboration across all involved teams.

Ensure compliance with regulatory requirements and industry standards in all CMC activities.

The ideal candidate will have a strong background in project management and CMC support, with the ability to lead cross-functional teams and manage complex projects in a dynamic environment.

Requirements

5+ years’ experience in bio tech/life sciences project management; cell Therapy experience preferred.

Bachelor’s degree in STEM/Life Sciences-related discipline.

Project management qualification preferred

Proficiency with related software tools such as: MS Project, Office Timeline Pro, Smartsheet, MS PPT, MS Excel, SharePoint, etc.

Strong knowledge of biopharma industry. Familiarity/experience with end-to-end CMC drug development.

Familiarity with alliance management

Excellent interpersonal, communication, and presentation skills.

Ability to work cross-functionally, with matrixed teams; maintaining strong business partner relationships.

Strong leadership skills and executive presence; ability to positively influence outcomes.

Expertise in conflict resolution.

Excellent critical thinking and problem-solving skills.

Willingness to do what needs to be done in a dynamic environment.

Benefits

System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.

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