Senior Manager, 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.

Position Summary:

Reporting to the Sr Director of Pharmaceutical Development, the Senior Manager 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.

Essential Duties and Responsibilities:

• Design and execute formulation and process development for small molecule DPs focusing on oral solid dosage forms. Evaluate data and communicate key findings to the team for decision making.
• Manage GMP drug product manufacturing, including directing day-to-day 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.
• Support registration-enabling activities such as process DOE, scale-up, tech transfer and registration batch manufacturing.
• Provide technical support on manufacturing investigations, impact assessment and CAPA.
• Collaborate with cross functional project team members to meet CMC goals.
• Author regulatory submissions (e.g., IND, IMPD, NDA, MAA).
• Function as a highly effective communicator and team player in a dynamic team culture.
• About 25% travel required, including domestic and international trips to support and oversee development and manufacturing activities as person-in-plant asional travel to other Erasca sites for meetings and company events.
• Perform all duties in keeping with the Company’s core values, policies and all applicable regulations.

Required Education, Experience and Attributes:

• Advanced degree in Pharmaceutics, Chemistry or related field. MS with 7+ years, or BS with 10+ years of progressive industry experience in pharmaceutical small molecule drug product development.
• Expertise and direct hands‑on experience in solid oral dosage formulation and manufacturing process development, including excipient selection and compatibility assessment, formulation development, stability study design, process scale up and GMP manufacturing. Experience in enabling technologies preferred.
• Direct experience working with CDMOs, including serving as point-of-contact and person-in-plant during process execution, troubleshooting, deviation investigation, technology transfer and scale-up.
• Ability to support global manufacturing operations across multiple time zones, including participating in evening meetings. Able to respond to manufacturing issues during production campaign in a timely manner.
• Familiarity with cGMP, ICH guidelines, FDA and global regulatory expectations and pharmaceutical quality systems.
• Good interpersonal skills and ability to build strong relationships with co-workers of various backgrounds and expertise. Demonstrated ability to influence without direct control. Ability to function in a team…