Erasca · South San Francisco, CA
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. ...
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.
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.
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.
Roll
Sr Manager/Assoc Director, Process Dev & Mfg
Kategori
Other
Plats
Publicerad
30 juli
Sista ansökningsdag
29 augusti
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