Director, CMC Project Management

This is a fully remote position, open to applicants in North Carolina.

📋 Description

• Oversee CMC planning initiatives that assist in late-stage and commercial CMC regulatory submissions, BLA filing, PLI, and subsequent approval.

• Recognize CMC deficiencies and implement a CMC strategy that is aligned across functions.

• Convert CMC strategy into actionable project plans, complete with specified deliverables and timelines.

• Lead cross-functional teams and manage interdependencies within Technical Operations.

• Create, maintain, and monitor comprehensive CMC plans and key milestones.

• Identify potential program risks and develop, as well as oversee, risk mitigation and contingency strategies.

• Conduct CMC gap assessments, risk evaluations, strategic discussions, and facilitate cross-functional decision-making processes.

• Provide data-driven recommendations regarding project continuation, acceleration, reprioritization, redesign, or termination.

• Generate status reports, document deliverables, and escalate any timeline delays, risks, or unresolved dependencies.

• Act as the primary CMC liaison for internal stakeholders and represent CMC during project team meetings.

• Supervise and prioritize project managers who are involved in CMC projects.

• Own the standards, templates, and scheduling for CMC planning.

• Relay project updates to team members and executives.

• Collaborate with Operations, QA, RA, and CMC teams on technology transfer, comparability, process scale-up, and validation activities.

• Contribute to CMC planning within Integrated Development and Integrated Project Plans.

• Report on a predetermined schedule to provide detailed CMC plan information for the Integrated Project Plan.

⛳️ Requirements

• Bachelor's degree in sciences or a related field; advanced degree (MS, PhD) preferred.

• A minimum of 12 years of relevant experience in the biopharmaceutical industry.

• At least 6 years of experience in cell therapy.

• Previous experience in CMC project management within a biotech or pharmaceutical company specializing in biologics, cell, and gene therapy.

• Experience in leading project managers or a project management team.

• Technical proficiency regarding the interdisciplinary aspects of cell therapy development.

• Adequate CMC knowledge to identify dependencies, risks, and gaps in manufacturing, quality, analytical, and regulatory activities.

• Proven success in effective collaboration with cross-functional CMC teams.

• Demonstrated capability to manage multiple tasks across product pipelines while supporting both short- and long-term corporate objectives.

• Strong ethical standards and a focus on compliance.

• Must be eligible to work in the United States without requiring a work visa or residency sponsorship.

🏝️ Benefits

• Equal employment opportunity employer.

• Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.