Sr Manager/Assoc Director, Process Dev & Mfg

📋 Description

• Design, execute experiments to develop scalable chemical synthesis processes
• Lead CDMO oversight and tech transfer for drug substances
• Plan DoE, QbD, and scale-up activities; impurity control
• Prepare plans, protocols, reports, and data summaries
• Collaborate with chemistry, analytical, QA, regulatory, and PM teams
• Travel up to 25% for CDMO oversight and project activities

🎯 Requirements

• PhD in organic chemistry with 7+ years in small-molecule work
• MS with 10+ years in synthetic organic chemistry
• Hands-on experience in synthetic organic chemistry and process development
• Experience scaling chemical processes at CDMOs or external sites
• Experience in synthesis, isolation, and crystallization of chiral molecules
• Knowledge of solid-form development; polymorph screening
• Strong knowledge of cGMP and ICH guidelines
• Experience applying DOE, QbD, and risk-based PD principles
• Ability to manage technical workstreams and deliver in fast-paced env

🎁 Benefits

• Medical, dental and vision plans
• Paid time off, holidays, and sick leave
• 401(k) with Erasca contributions and stock purchase option
• Annual bonus and equity grants at hire and ongoing
• Employee assistance program
• FSA/HSA and commuter benefits
• Pet insurance, life and disability coverage