Director of CMC

Responsibilities

• Develop and lead all GMP CMC-related activities for biologics and small molecules, including process chemistry, drug product, analytical, and formulation
• Build and lead an internal GMP CMC team covering process development, quality control, and quality assurance
• Manage external drug product manufacturing service providers and API supply chains to support clinical trial development
• Collaborate with pharma R&D teams to manage internal tech transfers and future CMC needs
• Author CMC sections of regulatory filings for FDA, EMA, and other national authorities
• Act as a subject matter expert for non-clinical CMC to support preclinical and clinical development teams
• Ensure high-quality standards by developing SOPs and implementing GMP compliance
• Monitor and report CMC timelines and budgets to the C-suite

Requirements

• 8+ years of CMC leadership experience advancing drug product development programs to successful clinical trials
• B.S. or M.S. in life sciences (e.g., Chemistry, Biochemistry, or related fields)
• Firm understanding of cGMP and FDA regulatory guidelines as they pertain to CMC
• Ability to work onsite in El Segundo, CA

Preferred Qualifications

• PhD in life sciences (Chemistry, Biochemistry, or related fields)
• 12+ years of CMC leadership experience
• Documented evidence of successful CMC project leadership from early to late phase clinical trials
• Experience managing research/analytical laboratories and manufacturing processes
• Command of global CMC-related regulatory requirements and guidelines
• Hands-on experience managing multiple stakeholders and CMOs

Benefits

• Equity in a fully funded space startup
• 401(k) matching
• Unlimited PTO
• Health insurance, including Vision and Dental
• On-site lunch and snacks, with dinners provided twice a week
• Maternity and Paternity leave

About the Company

Varda is accelerating the development of commercial space infrastructure, from in-orbit pharmaceutical processing to reliable and economical reentry capsules. Our mission is to expand the economic bounds of humankind by creating the products and infrastructure needed so space can directly benefit life on Earth.