Director of CMC

About this Role

Our pharmaceutical team is looking for a highly motivated and creative Director of Chemistry, Manufacturing and Control (CMC) to lead expansion and growth of partner pharma activities toward clinical production. This role will be responsible for all CMC activities across the external drug development pipeline of Varda’s partners. Reporting to the VP, Pharma Program Management), this position requires collaboration across multiple departments and external partners to design, develop, and implement novel approaches to manufacture drug products in low Earth orbit. This is an opportunity in an exciting area of growth for Varda, the role will shape Varda’s product culture and will play a significant role in establishing the low Earth orbit economy. The ideal candidate must create and lead the CMC development team for drug products from early stage through clinical manufacturing.

Responsibilities

• Develop and lead all GMP CMC-related activities (biologics and small molecule) including process chemistry, drug product, analytical, and formulation from lead optimization phase through to clinical development and commercialization  
• Build and lead internal GMP CMC team with functions around 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 Varda pharma R&D teams to understand future CMC needs and handle internal tech transfers 
• Author all CMC sections of regulatory filings including FDA, EMA and other national authorities to support the conduct of clinical trials 
• Act as subject matter expert for non-clinical CMC to both preclinical and clinical development teams, interact with all internal and external stakeholders to support CMC needs 
• Ensure high-quality standards, develop SOPs, implement GMP compliance and QC/QA 
• Monitor progress and regularly report to the C-suite team 
• Manage and monitor the CMC timelines and budget 

Basic Qualifications

• 8+ years of CMC leadership experience advancing drug product development programs to successful clinical trials 
• B.S. or M.S. in life sciences such as Chemistry, Biochemistry, or related fields 
• Firm understanding of cGMP and FDA regulatory guidelines as they pertain to CMC 

Preferred Skills and Experience

• 12+ years of CMC leadership experience advancing drug product development programs to successful clinical trials 
• PhD in life sciences such as Chemistry, Biochemistry, or related fields 
• Documented evidence of prior successful CMC project leadership from early phase, late phase leading to clinical trials. 
• Experience in leading and direct management of research, analytical laboratories, process development, and manufacturing 
• Advanced understanding of cGMP and FDA regulations and guidelines relating to CMC-related areas 
• Command of global CMC-related regulatory requirements and guidelines 
• Excellent leadership, managerial and communications skills in a cross functional environment 
• Hands-on experience in managing multiple internal and external stakeholders (e.g. working with CMOs on managing drug product development) 
• Experience with writing CMC sections for regulatory filings and knowledge of current regulations in US and EU 
• Fluent communication in English, written and verbal 

Pay Range

• Salary range: $200,000 - $230,000/per year
• This role is on-site in El Segundo, CA
• Leveling and base salary is determined by job-related skills, education level, experience level, and job performance
• You will be eligible for incentives in the form of stock options and/or long-term cash awards