Senior Project Manager – Cell Therapy Development and Operations / Manufacturing - TechDigital
Summit, NJ
About the Job
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 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. (GD: too specific?)
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:
Apply project management expertise across the portfolio for both standard and complex projects, managing multiple projects in parallel
Utilize sound project management judgement
Champion innovative project management tools and SDLC methodologies to support programs
Drive project management and portfolio solutions across cell therapy technical operations team
Define project scope / goals / deliverables / budget / timeline
Prepare and present the business cases for the assigned projects to the Leadership Team
Provide strong team leadership and drive to ensure projects are executed on time and within budget
Create project plans and manage dependencies, milestones and deliverables
Maintain project objectives throughout the project lifecycle
Monitor execution and quality to customer / stakeholder / sponsor standards
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
Report on project progress, offer viable solutions and opportunities as they arise
Implement appropriate project change control
Ensure the project teams for the assigned projects are following the current standards, policies, procedures and guideline and bridge the gap for the CTDO project teams when needed
Provide structure, leadership and if needed mentorship to team members to ensure team meets project objectives
Manage internal and external resources and stakeholder to ensure the project schedule and budget are on track
Manage vendors participating in the project including vendor selection, contracts and financials
Develop and communicate status to PMO, project team, and CTDO leadership
Partner with the project and workstream leads to successfully achieve project objectives
Facilitate all project team meetings; attend related project team meetings as necessary to ensure alignment
Evaluate and assess the project outcome
Competencies & Experiences:
5+ years of experience in GxP project management
5+ years of experience in CAR T / Cell Therapy or Biologics
Understanding of GMP and FDA regulatory requirements correlating to biologics
Bachelors/Masters degree in Life Sciences or technical field required
Project Management Professional (PMP) certification
Proficiency with related software tools such as: MS Project, OnePager, MS PPT, MS Excel, etc.
Experience with sharepoint, Smart Sheets, ServiceNow, etc.
Strong knowledge of biopharma industry. Familiarity/experience with end-to-end CMC drug development
Solid analytical skills and financial acumen
Proven record of successfully completing multi-million dollar projects
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
Ability to work cross-functionally, with matrixed teams
Excellent relationship-building skills including ability to foster productive, collaborative working relationships with business partners
Strong leadership skills and executive presence with ability to positively influence outcomes
Expertise in conflict resolution
Excellent critical thinking and problem-solving skills
Ability to think through and implement creative solutions
Ability to promote the spirit of proactive, continuous quality improvement
Willingness to do what needs to be done in a dynamic environment
Demonstrated high degree of independence, requiring minimal supervision from senior management
Desired Qualifications:
Highly-motivated, highly-organized, passionate self-starter: analytical, detail-oriented and operationally focused.
Comfortable with uncertainty and meeting tight deadlines in the matrix environment.
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
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 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. (GD: too specific?)
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:
Apply project management expertise across the portfolio for both standard and complex projects, managing multiple projects in parallel
Utilize sound project management judgement
Champion innovative project management tools and SDLC methodologies to support programs
Drive project management and portfolio solutions across cell therapy technical operations team
Define project scope / goals / deliverables / budget / timeline
Prepare and present the business cases for the assigned projects to the Leadership Team
Provide strong team leadership and drive to ensure projects are executed on time and within budget
Create project plans and manage dependencies, milestones and deliverables
Maintain project objectives throughout the project lifecycle
Monitor execution and quality to customer / stakeholder / sponsor standards
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
Report on project progress, offer viable solutions and opportunities as they arise
Implement appropriate project change control
Ensure the project teams for the assigned projects are following the current standards, policies, procedures and guideline and bridge the gap for the CTDO project teams when needed
Provide structure, leadership and if needed mentorship to team members to ensure team meets project objectives
Manage internal and external resources and stakeholder to ensure the project schedule and budget are on track
Manage vendors participating in the project including vendor selection, contracts and financials
Develop and communicate status to PMO, project team, and CTDO leadership
Partner with the project and workstream leads to successfully achieve project objectives
Facilitate all project team meetings; attend related project team meetings as necessary to ensure alignment
Evaluate and assess the project outcome
Competencies & Experiences:
5+ years of experience in GxP project management
5+ years of experience in CAR T / Cell Therapy or Biologics
Understanding of GMP and FDA regulatory requirements correlating to biologics
Bachelors/Masters degree in Life Sciences or technical field required
Project Management Professional (PMP) certification
Proficiency with related software tools such as: MS Project, OnePager, MS PPT, MS Excel, etc.
Experience with sharepoint, Smart Sheets, ServiceNow, etc.
Strong knowledge of biopharma industry. Familiarity/experience with end-to-end CMC drug development
Solid analytical skills and financial acumen
Proven record of successfully completing multi-million dollar projects
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
Ability to work cross-functionally, with matrixed teams
Excellent relationship-building skills including ability to foster productive, collaborative working relationships with business partners
Strong leadership skills and executive presence with ability to positively influence outcomes
Expertise in conflict resolution
Excellent critical thinking and problem-solving skills
Ability to think through and implement creative solutions
Ability to promote the spirit of proactive, continuous quality improvement
Willingness to do what needs to be done in a dynamic environment
Demonstrated high degree of independence, requiring minimal supervision from senior management
Desired Qualifications:
Highly-motivated, highly-organized, passionate self-starter: analytical, detail-oriented and operationally focused.
Comfortable with uncertainty and meeting tight deadlines in the matrix environment.
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
Source : TechDigital
