Associate Director/Director, Pharmaceutical Development

Responsibilities

• Provide scientific, technical, and strategic direction to the design, development, and manufacture of investigational drug products
• Manage contractual relationships with CDMOs for formulation development, manufacturing, and analytical testing
• Lead cross-functional project teams to meet CMC goals
• Represent CMC DP and provide strategic recommendations to program teams
• Author and review development reports, regulatory submissions (IND, IMPD, NDA, MAA), and SOPs
• Act as Subject Matter Expert for GMP regulations and ICH guidance
• Travel up to 25% for person-in-plant oversight

Requirements

• Advanced degree in Pharmaceutics, Chemistry, or a related field
• 10 to 12+ years of progressive experience in Biotech or Pharmaceutical industry
• Expertise in small molecule drug product development and manufacturing
• Experience managing CDMO relationships and regulatory submissions
• Familiarity with ICH guidelines and cGMP regulations
• Proven track record of scientific achievement and ability to influence without direct control

Preferred Qualifications

• Experience in enabling technologies
• Experience in solid oral dosage form manufacturing

Benefits

• Paid Time Off, Holiday, and Sick Leave
• Medical, Dental, and Vision Plans
• Short- and Long-Term Disability
• Basic and Voluntary Life/AD&D Coverage
• Flexible Spending Accounts (FSA, HSA, Commute)
• Critical Illness and Accident Coverage
• Pet Insurance and Employee Assistance Program
• 401(k) Plan with company contribution
• Employee Stock Purchase Program
• Annual bonus and equity grants

About the Company

Erasca is a clinical-stage precision oncology company focused on discovering, developing and commercializing medicines for the benefit of patients with cancer, specifically targeting the RAS/MAPK pathway.