Cell Therapy CMC Project Manager

Responsibilities:

• Excellent employment opportunity for a Cell Therapy CMC Project Manager in the Gaithersburg MD area. Onsite 100%
• 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.
• 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 plan & 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 crossfunctional project team and other key stakeholders
• Support implementation of strategic initiatives related to CMC project management

• Bachelors Masters 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 crossfunctional team management

Required Skills:

• Excellent interpersonal skills ability to develop relationships with key stakeholders good conflict management skills
• Strong communication skills
• 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 detailorientated 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

Desired Skills:

• Advanced degree within field
• Professional Project Management certification
• Business Strategy
• Combined experience of Project Management in a CMC or Process Development function