CMC Consultant

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a CMC Consultant in United States.

This role offers a unique opportunity to contribute to the development of a cutting-edge, device-enabled therapeutic product aimed at transforming how inflammatory skin conditions are treated. As a senior Chemistry, Manufacturing & Controls (CMC) expert, you will play a pivotal role in shaping and executing the development strategy for a novel combination product moving through the NDA pathway. Working in a highly collaborative and fast-paced biotech environment, you will provide both strategic guidance and hands-on execution across formulation, analytical development, and manufacturing. You will also act as a key liaison with external partners, including CDMOs, ensuring alignment on timelines, quality, and regulatory expectations. This position is ideal for a seasoned professional who thrives in a flexible, high-impact advisory role within a lean and innovative team.

• Define and execute the overall CMC strategy to support clinical development and regulatory milestones
• Oversee drug substance and drug product development in collaboration with external CDMOs, including formulation, stability, and device compatibility
• Establish critical quality attributes, specifications, and product acceptance criteria
• Lead and guide analytical method development, validation, and lifecycle management activities
• Manage and coordinate relationships with external vendors, suppliers, CDMOs, and CROs
• Support partner selection, onboarding, and ongoing oversight to ensure delivery timelines and quality standards
• Review technical deliverables, identify risks, and implement mitigation strategies across development programs
• Collaborate with regulatory teams to support IND, NDA, and other regulatory submissions and interactions
• Contribute to FDA meeting preparations and ensure inspection readiness across CMC activities

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Requirements:

• Advanced degree (Ph.D. preferred) in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related field
• 10+ years of experience in pharmaceutical or biotech CMC development with leadership responsibility
• Strong expertise in formulation development, analytical methods, GMP manufacturing, and quality systems
• Proven experience supporting IND submissions and contributing to NDA-stage development programs
• Deep understanding of FDA regulations, GMP guidelines, and global regulatory frameworks
• Experience working with external manufacturing partners (CDMOs) and managing outsourced development programs
• Strong ability to operate independently in fast-paced, early-stage or startup environments
• Experience with combination products (drug-device systems) strongly preferred
• Excellent communication, stakeholder management, and problem-solving skills
• Prior FDA interaction experience is a strong advantage