Associate Director/Director Process Chemistry
About The Position
The Associate Director, Process Chemistry supports drug substance activities internally and externally, working directly with CROs, CDMOs, and internal CMC and cross-functional teams to ensure on-time delivery and phase-appropriate process procedures. The role oversees process chemistry work for drug substance, with an emphasis on late-stage development and validation, and provides technical expertise for manufacturing, scale-up, validation, and troubleshooting as needed. It also supports drug substance regulatory content for U.S. and international submissions and contributes technical expertise to quality audits. This is a U.S.-based remote role requiring quarterly or as-needed visits to the San Francisco office. The position offers a market-competitive total rewards package including base pay, annual performance bonus, company equity, and health benefits. The stated California salary range is $177,400–$205,200.
Requirements
- Ph.D. in Organic Chemistry from Purdue University.
- At least 7 years of experience as a process chemist in industry.
- Experience leading route scouting, process development, scale-up, DOE, process validation, and CMC strategies for small-molecule drug substances.
- Experience authoring and reviewing regulatory documents, including INDs, NDAs, MAAs, CBE30, and Type II submissions.
Responsibilities
- Oversee CDMO process chemistry activities for drug substance, focusing on late-stage development and validation across international and U.S.-based CDMOs.
- Provide on-site technical support at CDMOs as needed for manufacturing, scale-up, and validation activities, and troubleshoot manufacturing or packaging process issues.
- Author and manage request-for-proposal documents to initiate work at CDMOs.
- Support and author drug substance content for CMC regulatory submissions in the U.S. and rest of world, focusing on late-stage development and marketing applications.
- Support Quality Assurance audits at CDMOs, remotely or on site, as a technical subject matter expert when needed.
- Interface proactively with CMC team members, including Analytical Chemistry, Formulation Development, Quality Assurance, and Supply Chain.
- Communicate Process Chemistry information clearly and regularly in verbal and visual presentation formats.
Benefits
- Annual performance bonus
- Company equity
- 401(k) with employer match
- Employee Stock Purchase Program (ESPP)
- Pre-tax commuter benefits for transit and parking
- Referral bonus for hired candidates
- Subsidized lunch and parking on in-office days
- Employer-paid medical, dental, and vision premiums for employees and dependents
- Health Savings Account with annual employer contributions
- Flexible Spending Accounts
- Fertility and family-forming benefits
- Mental health support, including therapy and coaching resources
- Flexible, take-what-you-need paid time off and company-paid holidays
- Paid medical and parental leave
- Continuous education and professional development programs
- Career pathing, internal mobility, and growth opportunities
- Peer-to-peer recognition
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
