Position: CMC Project Manager
Location: 101 Orchard Ridge Dr Gaithersburg, MD, 20878
Long Term
Summary of the position:
The CMC project manager (PM) in Oncology Cell Therapy Tech Ops (CTTO) will build project plans, coordinate delivery of CMC activities in line with project requirements, plan and monitor resources and expenses for product development and clinical manufacture. The CMC PM works collaboratively with CMC, manufacturing team leaders and key stakeholders to ensure project goals and milestones are achieved. The role provides project management expertise to CMC teams to ensure efficient planning and delivery of CTTO portfolio. This role leverages and applies project management experience where appropriate to interface with internal and external partners.
This role has a high job complexity and the successful candidate must have a demonstrated ability to work independently, with minimal supervision, to meet requirements outlined below.
Main Duties & Responsibilities:
Translate drug development and clinical development strategies into CMC project plans and deliverables (timeline, budget, resource plan, risk assessment, and milestones)
Create, manage and facilitate project team meetings, drive project team planning, develop meeting agendas, track and manage actions through to completion/resolution and pland & facilitate workshops
Leverage project management tools to drive planning, meeting discipline and project document management
Facilitate readiness for governance and senior leader interactions
Monitor risks in real time to ensure team engagement and mitigation plans are activated as required. Anticipate and resolve challenges affecting goals and objectives
Coordinate project updates; responsible for effective communications within project team and the the cross-functional project team and other key stakeholders
Support implementation of strategic initiatives related to CMC project management
Education & Experience Requirements:
Bachelor's, Master's, PhD or equivalent industry experience in a relevant technical discipline such as Biochemistry, Cell Biology, Molecular Biology, Immunology or Chemical Engineering.
Relevant experience in auto or allo cell therapy CMC project management
Experience in planning, managing, and executing functional and/or cross functional aspects of cell therapy product development is desired
The candidate will have demonstrated knowledge and application of Project Management tools
This position requires a high level of commitment, flexibility and independence with strong skills for planning, coordination, facilitation, driving collaboration, stakeholder communications and enabling efficient & effective cross-functional team management
Required Skills:
Excellent interpersonal skills, ability to develop relationships with key stakeholders, good conflict management skills
Strong communication skills and the ability to interact with a diverse group of individuals inside and outside of function
Effective problem solving and analytical skills to tackle and manage a broad range of issues and projects across a large organization and deliver innovative solutions
Professional, dedicated, proactive, and detail-orientated with ability to work with minimal supervision
Proven ability to proactively identify risks and resolve issues
Proven success in goal setting & delivery, resource planning, manage budget considerations, prioritization, and time management
Strong analytical and problem-solving capabilities.
Comfortable with ambiguity
Highly organized and able to work independently on multiple tasks in a fast-paced environment
Desired Skills:
Advanced degree within field
Professional Project Management certification
Business Strategy
Combined experience of Project Management in a CMC or Process Development function