Director, CMC Project Management

Director, CMC Project Management

An innovative biopharmaceutical company is seeking an experienced Director, CMC Project Management to lead Chemistry, Manufacturing, and Controls (CMC) projects supporting clinical trials, late-phase development, and commercialization efforts. This position plays a key role in ensuring seamless transitions from development to commercial readiness, including Biologics License Application (BLA) submission.

Key Responsibilities

Project Leadership:

• Lead cross-functional teams through late-phase development, BLA submission, and commercial launch.
• Develop and manage CMC project plans, timelines, and budgets.
• Collaborate with stakeholders to align on goals and deliverables.

BLA Submission & Commercial Readiness:

• Oversee preparation, review, and submission of CMC sections of regulatory filings.
• Ensure compliance with global regulatory standards (FDA, EMA, ICH).
• Coordinate manufacturing process validation, tech transfer, and quality system readiness.

Risk & Resource Management:

• Identify risks and implement mitigation strategies.
• Manage resource allocation across multiple programs.
• Provide regular project updates to leadership and stakeholders.

Cross-Functional Collaboration:

• Drive communication between internal teams and external partners (CDMOs, CROs, regulatory agencies).
• Foster operational and regulatory integration across departments.

Leadership & Mentorship:

• Lead and mentor project management team members.
• Contribute to best practices for CMC project and lifecycle management.

Qualifications

• 10+ years of experience in CMC project management within biopharma or biotech.
• Proven expertise in late-phase development, BLA submission, and commercialization.
• Strong knowledge of cGMP manufacturing, regulatory requirements, and biologics lifecycle management.
• Experience managing global, cross-functional teams.
• Proficiency in project management tools (e.g., MS Project, Smartsheet).
• PMP or equivalent certification.
• Preferred experience with biologics, monoclonal antibodies, rare diseases, or orphan drugs.

This is a high-impact role for a seasoned professional ready to drive critical CMC projects and lead a team through the transition to commercial success.