Director, Drug Product Development & CMC

Erasca, Inc.; San Diego (CA); Sur place; USD 215 000 - 240 000; Plein temps

Avantages offerts par ce poste

Paid Time Off

Holiday

Sick Leave

Medical Insurance

Dental & Vision plans

Short-Term Disability

Long-Term Disability

Life/AD&D Insurance

FSAs/HSA/Commuter benefits

Critical Illness & Accident Coverage

Pet Insurance

Employee Assistance Program

401(k) with Erasca contribution

Employee Stock Purchase Program

Résumé du poste

Erasca, Inc. in San Diego, CA, seeks a Director of Pharmaceutical Development to provide technical and strategic leadership for small molecule drug product development from early development through late-stage clinical development and registration.

The role oversees CDMOs for formulation, process development, clinical manufacturing, packaging, stability and validation. The ideal candidate will have 10–12+ years in biotech/pharma, strong ICH/cGMP knowledge, and the ability to influence across

Qualifications

• Advanced degree in pharmaceutics, chemistry or related field; highly preferred.
• 10–12+ years in biotech/pharma focused on small molecule drug product development and manufacturing.
• Experience managing relationships with CDMOs and knowledge of regulatory submissions.
• Familiarity with ICH guidelines and global cGMP requirements.
• Strong track record of scientific achievement and ability to influence without direct control.

Responsabilités

• Provide scientific and strategic leadership for design, development and manufacture of investigational drug products.
• Lead drug product development activities including formulation and process development, transfer, manufacturing, stability and validation.
• Manage relationships with CDMOs, contract labs and external partners.
• Collaborate with Process Development, Analytical Development, Regulatory CMC, QA, Supply Chain and others to meet objectives.
• Develop and execute CMC strategies to support development, registration and lifecycle management.
• Prepare, review and defend regulatory submissions and responses.
• Support health authority interactions, inspections and regulatory responses.
• Travel up to 25% domestically and internationally for meetings, transfers, audits and campaigns.

Connaissances

Leadership

CDMO management

Regulatory submissions

ICH guidelines

Cross-functional collaboration

Communication

Influence without authority

Formation

Advanced degree in Pharmaceutics, Chemistry or related field

Description du poste

Erasca, Inc. in San Diego, CA, seeks a Director of Pharmaceutical Development to provide technical and strategic leadership for small molecule drug product development from early development through late-stage clinical development and registration.

The role oversees CDMOs for formulation, process development, clinical manufacturing, packaging, stability and validation. The ideal candidate will have 10–12+ years in biotech/pharma, strong ICH/cGMP knowledge, and the ability to influence across