Director, CMC Project Management

A project management role with a strong analytical focus, responsible for overseeing Chemistry, Manufacturing, and Controls projects to ensure all quality and compliance requirements are met through to completion. This position works closely with scientific teams, as well as quality assurance, regulatory affairs, and clinical supply chain functions, to coordinate the manufacturing and release of drug substances and drug products. The role also provides guidance on timelines, budgets, analytics, and strategy to both internal teams and external partners, ensuring alignment with industry standards, regulatory expectations, and organizational goals while promoting operational excellence in drug development and manufacturing. This is a hybrid role (3 days a week in the office).

Responsibilities:

• Lead project management efforts to support ongoing drug substance and drug product manufacturing at CDMOs, with an emphasis on analytical aspects such as process validation, stability studies, and GMP production runs.
• Develop strategies and oversee the resolution of all analytical-related out-of-specification (OOS) issues at CMOs.
• Provide scientific insight, strategic direction, and hands-on project management to advance products through development, clinical supply, and commercialization stages.
• Plan and manage manufacturing timelines for drug substance and drug product activities, including coordination with CMOs, inventory tracking, invoice processing, document review, and ensuring effective information flow across teams.
• Coordinate meetings and communication among cross-functional groups, including drug substance, drug product, analytical development, quality assurance, regulatory affairs, and clinical development.
• Oversee the CMC budget and associated activities such as contracts, scope changes, and invoice management, working closely with senior leadership, finance, legal, and external partners.
• Drive analytical activities related to technology transfer, process scale-up, validation, and manufacturing at CDMOs, including final product assembly and release.
• Collaborate with the supply chain team to ensure proper shipment and final processing of all drug product batches.
• Manage the creation and execution of analytical plans, master batch records, study protocols, and supporting documentation for manufacturing operations.
• Partner with quality assurance and regulatory teams to establish specifications and stability programs in compliance with ICH guidelines.
• Assist in handling clinical product complaints, including logistics and investigations.
• Review external documentation (e.g., batch records, analytical data, validation protocols) and take appropriate action, particularly for analytical considerations.
• Analyze process and batch data, identify trends, and provide recommendations to resolve technical or quality issues efficiently.
• Contribute to the preparation of technical reports and CMC sections for regulatory submissions.
• Support the development of responses to inquiries from health authorities.

Required Skills:

• A bachelor’s degree or higher in analytical chemistry, bioengineering, biology, cell biology, chemical engineering, biochemistry, pharmacology, or a related scientific field (or equivalent practical experience).
• At least 12 years of relevant experience in the pharmaceutical or biotechnology industry, with work in Analytical Development, Quality Control, or drug substance/drug product manufacturing within an outsourced model involving CMOs/CDMOs.
• A minimum of 5 years of CMC project management experience, particularly in biologics process development—ideally including monoclonal antibodies and combination products such as prefilled syringes and vials.
• Strong analytical expertise with hands-on experience in assay development, transfer, validation, and QC activities throughout biologics manufacturing.
• Solid understanding of biologics manufacturing principles and standard practices.
• Familiarity with late-stage drug substance and drug product development, including process scale-up and technology transfer for biologics.
• Extensive knowledge and practical experience with analytical methods for biologics and device performance.
• Working knowledge of GMP regulations, global regulatory guidelines, and compendial standards (e.g., FDA, EMA, ICH, WHO, USP-NF, EP).
• Strong interpersonal skills and ability to collaborate effectively within cross-functional teams.
• Critical thinking skills and the ability to work independently.
• Comfort working in a fast-paced, evolving environment.
• Results-driven mindset with an interest in contributing to strategic business direction.
• Ability to navigate ambiguity and challenge existing approaches when needed.
• Proven capability to manage multiple high-priority projects with tight and competing timelines.
• Excellent written and verbal communication skills, with experience presenting to diverse audiences, including senior leadership.

Pay: $210,000 - $240,000 annually, 20% bonus, stock options