Associate Director CMC
Company Description:
Revelation Biosciences, Inc. is a clinical-stage biotech company dedicated to restoring immune balance by targeting inflammation through its proprietary Gemini formulation. The company is advancing a diverse pipeline of programs evaluating Gemini across multiple indications, including the treatment of chronic kidney disease, prevention of post-surgical infections, and management of acute kidney injury.
Position Overview
The Associate Director of Chemistry, Manufacturing, and Controls (CMC) will lead the strategic development, manufacturing, and regulatory compliance of pharmaceutical products at Revelation Biosciences. They will oversee technical projects, manage CDMO partnerships, and author/review CMC documentation for regulatory submissions (IND, BLA/NDA) to ensure compliance with global health authorities.
Duties and Responsibilities
CMC Leadership:
- Lead cross-functional CMC matrix teams to manage product development from clinical phases through commercialization.
Regulatory Submissions:
- Author, review, and manage CMC sections for INDs, CTAs, BLAs, and MAAs, ensuring compliance with ICH/EMA/FDA guidelines.
- Act as the CMC regulatory lead across programs, driving timelines, identifying risks, and ensuring proactive mitigation strategies in a resource-constrained, agile environment.
- Coordinate cross-functional inputs to support efficient submission preparation and responses to Health Authority queries.
Technical Oversight:
- Oversee drug substance/product development, process validation, technical transfer, and stability studies.
Partner Management:
- Serve as the primary interface with Contract Development and Manufacturing Organizations (CDMOs).
Education and Skills Requirements
- Bachelor’s degree (or higher) in Chemistry, Pharmacy or related scientific field.
- 5-10+ years in pharmaceutical CMC development, with 3+ years in regulatory affairs or project management.
- Experience supporting early-stage and clinical development programs, ideally within small or emerging biotech companies.
- Experience preparing and contributing to IND submissions and in regulatory requirements (FDA/EMA) for biologics or small molecules.
- Proven ability to lead projects, collaborate cross-functionally and influence in a small team setting.
- Strong communication and regulatory writing skills, with attention to detail.
- Strong understanding of the drug development lifecycle, especially in early clinical development environments.
- Ability to operate both strategically and tactically in a lean organization with evolving priorities.
