Project Manager III

Job Description:

CMC Project Manager

About the Opportunity:

The CMC Project Manager will be responsible for project management functions within the mRNA Center of Excellence, primarily focused on management of Chemistry, Manufacturing and Controls (CMC) activities for preclinical through early-stage (Ph1) development programs. The ideal candidate will have significant relevant experience and a track record of accomplishments in the life sciences/ pharmaceutical/biotechnology industry.

The CMC Project Manager will support the CMC subteam composed of cross-functional representatives from within and external to the mRNA CoE.

The successful candidate is expected to have a technical background (6 years of industry experience) in formulation development, process engineering, or chemistry with additional industry experience in project/program management in the pharmaceutical or biotech field developing clinical and commercial candidates.

Key Responsibilities:

• Support the CMC Leader in leading cross-functional CMC subteams to develop and execute the CMC strategy for development projects from pre-clinical through early stage (Ph1).


• Collaborate with multi-disciplinary team members to analyze/optimize development approaches and to develop detailed integrated operational project plans to achieve the project milestones. Ensure alignment of the CMC project plan with the Global project plan. Support resource planning and allocation (i.e. via Planisware) and cost planning activities.


• Apply project management expertise and best practices in the planning, initiation, execution and tracking of project activities.


• Lead regularly scheduled CMC subteam meetings to track activities, monitor progress, drive decision making, resolve issues, and identify/track risks and mitigation plans. Facilitate meetings through issuance of meeting agendas and minutes and tracking/follow up of action items.


• Manage project budget and track expenses.


• Serve as Scrum Master and organize/drive project sprints to achieve key deliverables. This includes backlog preparation, sprint planning, scrum meeting and retrospectives facilitation.


• Proactively monitor project progress and provide timely communications to the mRNA CoE Leadership Team, to the Global Project Team and to other key stakeholders regarding project status, critical path activities, resource requirements, and risks and mitigation strategies.


• Support functional workstream leaders and team members when required to enhance performance/execution of critical activities.


• Own and manage information sharing platform (i.e. Teams/Sharepoint) for CMC-Subteam.


• Participate in the development, implementation, and sustainability of standard project management tools and best practices within the mRNA CoE Global PMO.

Qualifications:

• 6 years of relevant experience in the biopharmaceutical industry.


• College or advanced degree in chemical, biomedical, biochemical, or process engineering, chemistry, materials sciences, or formulation sciences.


• Knowledge of typical CMC activities and requirements.


• Demonstrated success in managing multiple projects effectively and using project management tools. Excellent organizational skills with great attention to detail. PMP certification is a plus.


• Knowledge of and experience with implementing Agile/Scrum methodologies is a plus.


• Strong interpersonal skills, self-awareness and ability to manage team dynamics.


• Strong written and oral communication skills, with demonstrated experience managing cross-functional communication. Excellent presentation skills and comfortable presenting to leadership and other key stakeholders.


• Strong and collaborative work ethic. Results oriented and demonstrates a focus on achieving (business) results.


• Demonstrated ability to facilitate project team meetings, enhance cross-functional communication, support decision making, influence outcomes, and ensure alignment among internal and external stakeholders.


• Knowledge and understanding of laboratory terminology, good documentation, and good laboratory practices. Experience and demonstrated proficiency in global GxPs, industry guidance (esp., ICH Q6 - Q12) and compliance with the same.


• Excellent knowledge with all aspects of MS Office including MS Project and Visio, Sharepoint and MS Teams.