Associate Director/Director, Process Chemistry

Role Summary

Associate Director/Director, Process Chemistry. Lead process chemistry activities for drug substance development, overseeing CDMOs, ensuring GMP compliance, and guiding late-stage development and validation within the CMC team. Remote in the U.S. with periodic travel to the San Francisco office.

Responsibilities

• Oversee contract development and manufacturing organizations (CDMOs) to Process Chemistry activities for drug substance (DS) with a focus on late stage and validation
• Experience working across International and US based CDMO’s
• Regularly and clearly communicate Process Chemistry both verbally and in visual presentation form, efficiently and contextually
• Author and manage request for proposal documents to initiate work at CDMO’s
• Support and author DS content for CMC Regulatory for US and Rest of World with focus on late stage development and marketing applications
• Support Quality Assurance audits, on site at CDMO’s or remotely, as a technical subject matter expert, as needed
• Provide on-site technical support at CDMO’s on an as-needed basis to oversee various manufacturing/scale-up/validation activities. Provide technical expertise to troubleshoot manufacturing/packaging process issues
• Proactively interface effectively with other CMC team members (e.g., Analytical Chemistry, Formulation Development, Quality Assurance, Supply Chain, etc.)

Qualifications

• Degree (MS or Ph.D.) in synthetic chemistry
• 10+ years of pharmaceutical small molecule manufacturing/process chemistry experience
• Strong technical background in small molecule large-scale manufacturing, late-stage process development, and commercialization of APIs
• Familiarity with state-of-the-art technology development and implementation to improve manufacturing processes and analytical methodologies
• Fundamental understanding of GMPs, quality, and regulatory requirements
• Proven ability to manage CDMO’s to achieve goals on aggressive timelines
• Thorough understanding of broad CMC aspects concerning the development, manufacturing, and analysis of small molecule therapeutics
• Experience with reviewing master batch records, executed batch records, manufacturing deviations, and investigations
• Excellent working knowledge of process safety, QbD, PAT, and DOE
• Experienced in the use of systematic investigation techniques to identify causes of process deviations, e.g., root cause analysis
• Well-versed in the preparation of FMEAs
• Comfortable using statistical software and techniques to define experimental plans and interpret results (e.g., JUMP, StatEase). Six Sigma certification is a plus
• Excellent verbal and written communication/interpersonal skills, problem-solving skills, organizational skills, and the ability to work in a diverse team environment
• Strong initiative and desire to work in a fast-paced, team-oriented, dynamic environment
• Proficiency with Microsoft software (Word / Excel / PowerPoint)
• Position requires up to 20% travel
• Strong focus on quality and attention to detail

Skills

• Process chemistry leadership
• CDMO management
• GMP and regulatory familiarity
• DS/CMC regulatory documentation
• QA audit support
• Scale-up and manufacturing troubleshooting
• Cross-functional collaboration
• Statistical tools (JUMP, StatEase)

Education

• MS or Ph.D. in synthetic chemistry

Additional Requirements

• Travel up to 20%