Attovia Therapeutics, Inc., is seeking a Director of CMC management to lead CMC regulatory strategy, submissions, and support the activities of our external CDMO for our biologics pipeline. Reporting to the Head of CMC, this role is responsible for preparation of CMC regulatory filings, providing technical guidance to CDMO on drug substance and drug product development and manufacturing, and ensuring CMC compliance with all applicable regulations. This role partners closely with Quality, Portfolio management, and Regulatory Affairs teams to ensure timely delivery of CMC regulatory sections and timely supply of clinical products.
Key ResponsibilitiesCMC Regulatory
- Develop CMC regulatory strategy aligned with product development pipeline and clinical pathways
- Identify and interpret applicable regulations, ICH guidelines, and agency expectations for CMC compliance
- Author the CMC sections of regulatory filing and partner with Regulatory Affairs to ensure they are complete on time
- Manage manufacturing-related responses and regulatory correspondence
- Ensure CDMO manufacturing data, site information, and quality documentation are organized for regulatory submissions
CDMO Management
- Provide technical guidance to CDMO on process development, analytical method development, formulation optimization, manufacturing, etc. to ensure CMC compliance with all regulatory requirements
- Coordinate with Quality team on batch testing, release criteria, and manufacturing data review
- Support supply chain management including shipment of non-clinical and clinical materials from CDMO
Strategic Collaborations
- Collaborate with internal functions on regulatory strategy, program timelines, manufacturing milestones, and CMC deliverables.
- Ensure CMC activities align with clinical development, regulatory submissions, and commercial launch timelines
- Work with external CMC consultants and support the development of commercial CMC strategy aligned with regulatory pathway
Basic Qualifications- Ph.D. in Chemistry, Biochemistry, Chemical Engineering, Pharmaceutical Sciences, or related field
- 10+ years of biopharmaceutical CMC development or regulatory affair experience
- Experience in process development, analytical methods, or formulation of protein therapeutics
- Deep regulatory knowledge and experience with FDA/EMA submissions
Preferred Qualifications- Cross functional experience leading or coordinating CMC development in a biotech or pharmaceutical company
- Experience in managing CMC transitions from development to commercial manufacturing and supporting BLA filing
- Strong technical writing, investigative, and risk assessment skills.
- Ability to work independently and manage multiple vendor relationships with minimal direct supervision
Attovia is located in San Carlos, CA.
$200,000 - $250,000 a year
Leveling and salary is commensurate with experience.
