Sr Manager/Assoc Director, Process Dev & Mfg

Erasca is 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 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

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

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.

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.

Erasca, Inc., is an Equal Opportunity Employer and takes pride in maintaining a diverse and inclusive environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of sex , race, religion, national origin, ancestry, physical or mental disability, protected medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military and veteran status or any other basis protected by federal, state or local law or ordinance or regulation.