Director, CMC Program Management

Job Description

• Lead the strategic planning and execution of CMC programs for cell therapy products from early development through commercialization. • Collaborate cross-functionally with R&D, Manufacturing, Quality, Regulatory Affairs, and other departments to drive program success and alignment with business objectives. • Develop and manage program timelines, budgets, and resources to meet project milestones and deliverables. • Identify and anticipate CMC-related risks/constraints to timing and resources. • Provide strategic guidance and oversight for CMC-related regulatory submissions, including IND, BLA, and other regulatory filings. • Drive continuous improvement initiatives to optimize CMC processes, systems, and workflows. • Lead and mentor a team of program managers and specialists to ensure high performance, collaboration, and professional development.

Qualifications

• A minimum of BA or BS degree in a technical, engineering or life sciences discipline; an advanced degree in business or in a scientific field is desirable. • A minimum of ten (10) plus years in pharmaceutical or biotechnology industry with a focus on CMC project management, drug development, manufacturing, or related areas

Benefits

• Not specified in the job opening