Assoc Director/Director, Pharmaceutical Development

📋 Description

• Direct design, development, and manufacture of DP.
• Lead cross-functional CDMO partnerships for DP development and testing.
• Coordinate internal and external teams to meet CMC goals.
• Represent CMC DP and report status to program teams.
• Author and review regulatory submissions (IND/NDA/MAA) and SOPs.
• Ensure GMP/ICH/cGMP adherence for DP manufacture; travel up to 25%.

🎯 Requirements

• Advanced degree in Pharmaceutics, Chemistry, or related field preferred.
• 10-12+ years in biotech/pharma small molecule DP development and manufacturing.
• Experience with DP validation and regulatory submissions with CDMOs.
• Familiarity with ICH guidelines and cGMPs across multiple countries.
• Strong communication and collaboration; ability to influence cross-functional teams.
• Willingness to travel up to 25% to oversee development activities.

🎁 Benefits

• Medical, dental, and vision plans.
• Paid time off, holidays, and sick leave.
• Short- and long-term disability coverage.
• Basic and voluntary Life/AD&D coverage.
• FSA, HSA, and commuter benefits.
• 401(k) with Erasca match and Employee Stock Purchase Plan.