Fractional CMC Technical Lead​/Consultant

Position: Fractional CMC Technical Lead / Consultant
Position Summary

We are seeking an experienced, hands‑on CMC (Chemistry, Manufacturing, and Controls) Consultant to provide technical oversight of small‑molecule drug development and support quality and regulatory readiness as the organization advances its clinical programs.

This fractional role will serve as the technical lead and primary point of oversight for external API manufacturing partners and Contract Research Organizations (CROs), ensuring appropriate chemistry, manufacturing processes, documentation, and quality standards are maintained. The consultant will also support regulatory CMC activities, including contributions to IND preparation and regulatory discussions.

The ideal candidate brings approximately 10+ years of relevant experience in small‑molecule pharmaceutical development, a strong technical chemistry background, and practical quality and regulatory expertise. This individual must be comfortable operating in a lean biotech environment, working independently, and balancing strategic oversight with hands‑on execution.

Key Responsibilities CMC Technical Leadership and CRO Oversight

• Provide technical leadership and oversight of external API manufacturers and CRO partners to ensure appropriate chemistry, manufacturing processes, and technical deliverables.
• Review and assess chemistry, manufacturing data, and supporting documentation for accuracy, completeness, and alignment with development requirements.
• Serve as the primary technical point of contact for external manufacturing partners, identifying and resolving issues as they arise.
• Ensure appropriate oversight of the API manufacturing process, including chemistry, process controls, and documentation supporting drug development.
• Maintain a pragmatic, execution-focused approach to CMC activities, prioritizing critical‑path deliverables and program milestones.

Quality and Documentation

• Provide practical quality oversight to ensure appropriate documentation, records, and supporting technical information are in place.
• Review relevant manufacturing and quality documentation for completeness, consistency, and readiness for regulatory use.
• Help establish or refine fit-for-purpose processes and documentation where needed, without introducing unnecessary complexity.
• Identify documentation gaps or quality concerns and work collaboratively with internal stakeholders and external partners to address them.

Regulatory CMC Support

• Partner with the regulatory CRO to support CMC components of regulatory submissions, including contributions to IND preparation.
• Provide technical input into regulatory CMC discussions and support preparation for interactions with regulatory authorities, including the FDA as applicable.
• Ensure consistency between manufacturing documentation, CMC data, and information prepared for regulatory submissions.
• Collaborate with regulatory partners to support clinical development programs initially targeting Europe, with subsequent Phase 2 development planned in Europe and the United States.

Cross-Functional Collaboration

• Work closely with company leadership, regulatory partners, API manufacturers, and other external development partners.
• Translate technical CMC considerations into practical recommendations that support development timelines and regulatory readiness.
• Operate effectively in a resource-constrained biotech environment, taking ownership of deliverables and adapting to evolving priorities.

Required Qualifications

• Approximately 10+ years of relevant experience in pharmaceutical development, CMC, process chemistry, API manufacturing, or a related discipline.
• Demonstrated experience with small‑molecule drug development
  , ideally through Phase 2 clinical development.
• Strong technical understanding of chemistry, API…