Position Summary:
Reporting to the Executive Director, Process Development and Manufacturing, the Senior Manager or Associate Director, Process Development and Manufacturing is a hands-on technical contributor responsible for designing and executing experiments that support process development and for coordinating and providing technical oversight of contract development and manufacturing organizations (CDMOs). This role supports small-molecule programs from research through clinical development and preparation for commercial production.
The Senior Manager or Associate Director may serve as the drug substance lead for one or more programs and works independently and collaboratively to plan, execute, interpret, and communicate process development and manufacturing activities across internal and external teams
Essential Duties and Responsibilities:
- Independently design, execute, and interpret laboratory experiments to develop robust and scalable chemical synthesis processes for starting materials, intermediates, and APIs
- Plan and execute phase-appropriate process R&D activities, including reaction optimization, workup, isolation, crystallization, impurity control, and scale-up
- Prepare experimental plans, protocols, technical reports, process descriptions, and data summaries that support project decisions and knowledge transfer
- Support technical transfer of starting material, intermediate, and API processes to CDMOs and between external manufacturing sites
- Collaborate closely with medicinal chemistry, analytical development, drug product, quality, regulatory, and project management colleagues
- Serve as drug substance lead or technical representative for assigned programs, coordinating deliverables, timelines, risks, and technical decisions with guidance from senior leadership as appropriate
- Provide day-to-day technical oversight of CDMO development and manufacturing activities, including review of protocols, batch records, data, deviations, investigations, and reports
- Conduct impurity fate and purge studies, evaluate potentially mutagenic impurities, and contribute to phase-appropriate drug substance control strategies
- Apply Design of Experiments (DOE), Quality by Design (QbD), risk assessment, and statistical approaches to build process understanding and define operating ranges
- Support process characterization, proven acceptable range studies, pre-validation, process performance qualification, and validation activities for drug substance manufacturing, as appropriate to program stage
- Review proposals and scopes of work from CDMOs and CROs and contribute to technical due diligence, vendor selection, and budget planning
- Author and review relevant CMC sections and supporting documentation for U.S. and ex-U.S. regulatory submissions
- Share technical expertise with colleagues and may provide project-level guidance or mentorship to junior scientists; direct people management is not a primary responsibility
- Travel up to 25% for CDMO oversight, technology transfer, manufacturing support, and other critical project activities
- Perform all duties in alignment with the Erasca's core values, policies, and applicable regulations
Required Education, Experience and Attributes:
- PhD in organic chemistry or a related field with typically 7+ years of relevant industry experience, or MS with typically 10+ years of relevant industry experience, in synthetic organic chemistry and small-molecule drug development
- Strong hands-on experience in synthetic organic chemistry and small-molecule process development, including laboratory execution, data interpretation, and troubleshooting
- Experience developing and scaling chemical processes at CDMOs or supporting external manufacturing activities
- Experience in chemical development involving synthesis, isolation, and crystallization of chiral molecules preferred
- Working knowledge of solid-form development, including polymorph screening, crystallization optimization, and related analytical techniques
- Strong knowledge of cGMP and relevant ICH guidelines and an understanding of phase-appropriate drug substance development and control strategies
- Experience applying Design of Experiments (DOE), Quality by Design (QbD), and risk-based process development principles
- Ability to independently manage technical workstreams, prioritize multiple activities, identify risks, and deliver high-quality work in a fast-paced environment
- Ability to build effective working relationships with colleagues and external partners across diverse backgrounds and areas of expertise
- Excellent written and verbal communication skills, with the ability to clearly present technical data, conclusions, risks, and recommendations
- Collaborative, solutions-oriented, intellectually curious, and willing to contribute as an individual contributor wherever needed
- Strong learning orientation, curiosity, and commitment to science and patients
The anticipated salary range for this position is $180,000 to $215,000. 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.