Senior Project Manager – Cell Therapy Development and Operations / Manufacturing

TechDigital Group; Summit (NJ); On-site; USD 90,000 - 150,000; Full time

Job summary

An established industry player is seeking a Senior Project Manager to lead complex projects in cell therapy development and operations. This role demands a proactive leader with a proven track record in GxP project management and a deep understanding of regulatory requirements. You will manage critical projects, ensuring alignment with strategic objectives while fostering collaboration across cross-functional teams. The ideal candidate will exhibit exceptional communication skills and the ability to navigate tight deadlines in a dynamic environment. Join a forward-thinking organization where your expertise will drive impactful results in the biopharma sector.

Qualifications

• 5+ years of experience in GxP project management and CAR T / Cell Therapy.
• Must have PMP certification and strong analytical skills.

Responsibilities

• Manage multiple complex projects ensuring alignment with company goals.
• Lead project teams and ensure timely execution within budget.

Skills

GxP project management

Cell Therapy

FDA regulatory requirements

Analytical skills

Leadership skills

Conflict resolution

Problem-solving skills

Communication skills

Education

Bachelor's degree in Life Sciences

Master's degree in technical field

Tools

MS Project

OnePager

MS PPT

MS Excel

SharePoint

Smart Sheets

ServiceNow

Job description

Senior Project Manager – Cell Therapy Development and Operations / Manufacturing

50% onsite required

Senior Project Manager – Cell Therapy Development and Operations / Manufacturing. Cell Therapy Development and Operations Senior Project Manager (CTDO Sr.PM) will influence and manage all aspects of initiating, planning, and executing complex, multi-disciplinary CTDO projects throughout the projects' lifecycle.

As a certified PMP with a breadth of hands-on project management experience in the Pharma/Biotech/Cell Therapy regulated environments, the CTDO Sr.PM is expected to perform with minimal supervision and effectively facilitate the successful delivery of a wide range of process development and commercialization activities within the CTDO organization from initiation to completion while remaining aligned with company strategy, commitments and goals.

The primary focus of the CTDO Sr.PM will be to manage critical CTDO projects in support of specific product programs. The CTDO Sr.PM will work closely with functional leadership and representatives to ensure alignment and coordination across CTDO priorities.

The CTDO Sr.PM will be responsible for using PMO best practices, tools and templates. Ideally, the successful candidate will be proficient in the project management standards, processes, procedures and guidelines of the Client heritage organizations (hClegene, hJuno, hBMS) and is capable of bridging the procedural gap for the CTDO project teams.

The successful candidate must have a proven record of extensive professional experience and the drive to steer both internal and external partners to efficient delivery of the projects. The incumbent must have the demonstrated ability to lead projects in a highly-matrixed and cross-functional organization, against tight deadlines, and with world-class partners, suppliers and business leaders alike.

Primary Responsibilities:

1. Apply project management expertise across the portfolio for both standard and complex projects, managing multiple projects in parallel.
2. Utilize sound project management judgement.
3. Champion innovative project management tools and SDLC methodologies to support programs.
4. Drive project management and portfolio solutions across cell therapy technical operations team.
5. Define project scope / goals / deliverables / budget / timeline.
6. Prepare and present the business cases for the assigned projects to the Leadership Team.
7. Provide strong team leadership and drive to ensure projects are executed on time and within budget.
8. Create project plans and manage dependencies, milestones and deliverables.
9. Maintain project objectives throughout the project lifecycle.
10. Monitor execution and quality to customer / stakeholder / sponsor standards.
11. Identify, handle and resolve project-related issues and risks by developing specific action / risk mitigation / contingency plans and escalating early to upper level management when necessary.
12. Report on project progress, offer viable solutions and opportunities as they arise.
13. Implement appropriate project change control.
14. Ensure the project teams for the assigned projects are following the current standards, policies, procedures and guidelines and bridge the gap for the CTDO project teams when needed.
15. Provide structure, leadership and if needed mentorship to team members to ensure team meets project objectives.
16. Manage internal and external resources and stakeholders to ensure the project schedule and budget are on track.
17. Manage vendors participating in the project including vendor selection, contracts and financials.
18. Develop and communicate status to PMO, project team, and CTDO leadership.
19. Partner with the project and workstream leads to successfully achieve project objectives.
20. Facilitate all project team meetings; attend related project team meetings as necessary to ensure alignment.
21. Evaluate and assess the project outcome.

Competencies & Experiences:

1. 5+ years of experience in GxP project management.
2. 5+ years of experience in CAR T / Cell Therapy or Biologics.
3. Understanding of GMP and FDA regulatory requirements correlating to biologics.
4. Bachelors/Masters degree in Life Sciences or technical field required.
5. Project Management Professional (PMP) certification.
6. Proficiency with related software tools such as: MS Project, OnePager, MS PPT, MS Excel, etc.
7. Experience with SharePoint, Smart Sheets, ServiceNow, etc.
8. Strong knowledge of biopharma industry. Familiarity/experience with end-to-end CMC drug development.
9. Solid analytical skills and financial acumen.
10. Proven record of successfully completing multi-million dollar projects.
11. Exceptional communication skills including ability to take an independent stance when interfacing with cross-functional stakeholders. Demonstrated focus on being able to translate data and metrics into predictable, value-add business insight.
12. Ability to work cross-functionally, with matrixed teams.
13. Excellent relationship-building skills including ability to foster productive, collaborative working relationships with business partners.
14. Strong leadership skills and executive presence with ability to positively influence outcomes.
15. Expertise in conflict resolution.
16. Excellent critical thinking and problem-solving skills.
17. Ability to think through and implement creative solutions.
18. Ability to promote the spirit of proactive, continuous quality improvement.
19. Willingness to do what needs to be done in a dynamic environment.
20. Demonstrated high degree of independence, requiring minimal supervision from senior management.

Desired Qualifications:

1. Highly-motivated, highly-organized, passionate self-starter: analytical, detail-oriented and operationally focused.
2. Comfortable with uncertainty and meeting tight deadlines in the matrix environment.
3. Proficient in heritage Client, heritage Juno/JuMP and Client project management standards/processes/procedures, and capable of bridging the gap in this regard for the JuMP project teams.