CMC Program Manager
Reporting to the SVP Program and Alliance Management, the CMC Program Manager is responsible for the management of integrated CMC development and manufacturing projects ensuring alignment with line functions and across strategic/operational/tactical plans, in support of the overall objectives and priorities of the program. This position is with a Contract Manufacturing Organization (CMO), located in Bristol, PA and candidates must be able to work on-site.
Work with clients, PMs, and cross-functional CMC teams to define project strategy, scope, milestones and deliverables to support business objectives in collaboration with senior management and stakeholders.
Create agendas, minutes and presentations to lead project team meetings and ensure action items are completed.
Work with Finance to ensure that appropriate budgets and forecasts are maintained to deliver agreed upon milestones.
Track personnel, equipment and facility resources and capacity.
Develop presentations, analyses and recommendations for the executive leadership and stakeholders.
Proactively identify risks and identify/implement mitigation plans.
Raise and clearly communicate critical issues and their impact to the appropriate stakeholders in a manner that results in resolution and allows others to do the same.
Effectively communicate project expectations to team members and stakeholders in a timely and clear manner.
MS/PhD in Life Science, Engineering or related field
10+ years CMC experience in small molecules, biologics, or antibody drug conjugates and broad knowledge of all aspects of CMC including process development, regulatory and quality requirements, analytical development, formulation and drug product technologies.
10+ years project management experience, leading multiple complex projects/programs
Broad knowledge of project management best practices and proficiency with supporting project management tools. PMP or another project management certification preferred.
Excellent written and oral communication skills. Outstanding presentation skills.
Analytical and problem-solving skills - must be able to troubleshoot critical issues or problems, determine causes and determine and implement solutions.
Demonstrated ability to organize, lead, and execute on a variety of assignments and action plans.
Posted On: Wednesday, November 24, 2021