Assoc Director, Pharmaceutical Development

Assoc Director, Pharmaceutical Development

Erascais a clinical-stage precision oncology company focused on discovering, developing and commercializing medicines for the benefit of patients with cancer. Our programs take novel approaches to shutting down one of cancer’s most commonly mutated signaling cascades, the RAS/MAPK pathway, which affects approximately 5.5 million lives each year worldwide. The name “Erasca” has an important embedded meaning: it is a contraction of our audacious hope to “erase cancer” that drives our mission and everything that we do on behalf of patients with cancer.

Reporting to the Sr Director of Pharmaceutical Development, the Associate Director of Pharmaceutical Development will be responsible for overseeing the manufacture of Erasca’s small molecule drug products (DPs) at contract development and manufacturing organizations (CDMOs). This individual will serve as the primary operational and technical liaison between internal cross functional teams and CDMOs to plan, coordinate, and execute DP development and manufacturing activities.

• Manage day-to-day clinical drug product manufacturing activities at CDMOs to ensure timely delivery.
• Coordinate manufacturing campaigns to ensure alignment of technical requirements, schedules, materials and documentation.
• Review and approve master batch records, executed batch records, protocols, reports, deviations, investigations, CAPAs, change controls and other GMP documents.
• Provide technical leadership on manufacturing investigations, impact assessment and CAPA.
• Lead and collaborate with cross functional project team members to meet CMC goals.
• Represent CMC DP and provide strategic recommendations and status reporting to cross-functional program team.
• Author, review, and/or approve development reports, regulatory submissions (e.g., IND, IMPD, NDA, MAA), and SOPs.
• Act as Subject Matter Expert for knowledge of GMP regulations, ICH guidance, and current regulatory expectations regarding DP manufacture and process control.
• Function as a highly effective communicator and team player in a dynamic team culture.
• Up to 25% travel will be needed to oversee development and manufacturing activities as person-in-plant
• Perform all duties in keeping with the Company’s core values, policies and all applicable regulations.

• Advanced degree in Pharmaceutics, Chemistry or related field with 8+ years of progressive industry experience in pharmaceutical small molecule drug product development.
• Strong hands-on experience in solid oral dosage formulation and manufacturing process development, including technical transfer and scale-up. Experience in enabling technologies preferred.
• Experience managing relationships with contract manufacturing organizations.
• Familiarity with ICH guidelines and regulatory expectations relevant to drug development and cGMPs including regulations in multiple countries.
• A strong track record of scientific achievement.
• Demonstrated ability to influence without direct control.
• Ability to build strong relationships with co-workers of various backgrounds and expertise.
• Ability to function at a high level in a team setting whether as manager, lead scientist, or individual contributor.
• Demonstrated ability to achieve high performance goals and meet deadlines in a fast-paced environment.
• Effective interpersonal and communication skills; a collaborative team player with a can-do attitude and the ability to identify and implement creative solutions to complex technical problems. Willing to contribute as an individual contributor whenever needed.
• Strong learning orientation, curiosity, and passion for science and patients.

The anticipated salary…