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 at CDMOs. Occasional 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 setting whether as manager, lead scientist, or individual contributor.
- Strong learning orientation, curiosity, and passion for science and patients.
The anticipated salary range for this position is $185,000 to $205,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etcetera. In addition to base salary, the hired applicant will be eligible to receive an annual bonus and an equity grant at hire and annually in the form of the option to purchase stock in the future for a specified price.
Along with our casual, collaborative, and fun work and the chance to make your mark in our mission to erase cancer, Erasca offers a comprehensive and competitive benefits package that includes: 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, and Commute), Critical Illness and Accident Coverage, Pet Insurance, Employee Assistance Program, 401(k) Plan with Erasca contribution, and the opportunity to participate in an Employee Stock Purchase Program.
