Assoc Director or Director, Process Development & Manufacturing jobs in United States
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Erasca, Inc. · 6 hours ago

Assoc Director or Director, Process Development & Manufacturing

Erasca is a clinical-stage precision oncology company focused on discovering, developing and commercializing medicines for the benefit of patients with cancer. The Director/Associate Director, Process Development and Manufacturing is responsible for the design and execution of experiments to support process development and for providing technical oversight of contract development and manufacturing organizations for small-molecule programs.

BiotechnologyLife ScienceOncologyPharmaceutical

Responsibilities

Design, develop, and implement robust chemical synthesis processes for starting materials, intermediates, and APIs to support research and development programs
Lead phase-appropriate process R&D activities to support early- and late-stage programs
Support technical transfer of starting material, intermediate, and API processes between internal and external sites as needed
Collaborate closely with medicinal chemistry teams during lead optimization and candidate selection
Serve as drug substance lead on one or more programs, providing technical leadership and project oversight
Conduct fate and purge studies, evaluate mutagenic impurities, and establish control strategies for drug substance processes with a long-term commercial vision
Work cross-functionally to ensure seamless transitions between drug substance and drug product programs and vendors
Critically review proposals from CMOs and CROs and perform appropriate technical due diligence to ensure suitability and capability
Oversee and support PAR studies, pre-validation, and validation activities for drug substance manufacturing
Author and review relevant CMC sections for U.S. and ex-U.S. regulatory submissions
Travel up to 25% for scientific project management, CDMO oversight, and monitoring of critical project activities
Perform all duties in alignment with Erasca’s core values, policies, and applicable regulations

Qualification

Synthetic organic chemistrySmall-molecule drug developmentChemical developmentCGMP knowledgeDesign of Experiments (DOE)Quality by Design (QbD)Learning orientationInterpersonal skillsCommunication skillsTeam collaboration

Required

Advanced degree (PhD or MS) in organic chemistry or a related field, with extensive industry experience (typically 10+ years) in synthetic organic chemistry and small-molecule drug development
Hands-on laboratory experience in synthetic organic chemistry and small-molecule process development
Strong understanding of synthetic and analytical techniques for polymorph screening, optimization, and patent protection
Thorough knowledge of cGMP, ISO, and ICH guidelines and industry best practices
Experience applying Design of Experiments (DOE) and Quality by Design (QbD) principles
Demonstrated experience managing and overseeing development and manufacturing activities at CDMOs
Ability to build strong, effective relationships with colleagues across diverse backgrounds and areas of expertise
Proven ability to function at a high level as a manager, technical lead, or individual contributor in a team-based environment
Track record of achieving high-performance goals and meeting deadlines in a fast-paced setting
Excellent interpersonal and communication skills; collaborative, solutions-oriented, and willing to contribute where needed
Strong learning orientation, intellectual curiosity, and commitment to science and improving patient outcomes

Preferred

Experience in chemical development involving synthesis and crystallization of chiral molecules preferred

Benefits

Paid Time Off
Holiday
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
Opportunity to participate in an Employee Stock Purchase Program

Company

Erasca, Inc.

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Our mission at Erasca is embedded in our name: To erase cancer.

Funding

Current Stage
Public Company
Total Funding
$629M
Key Investors
Partner Fund Management
2024-05-16Post Ipo Equity· $184M
2024-03-27Post Ipo Equity· $45M
2022-12-09Post Ipo Equity· $100M

Leadership Team

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Jonathan Lim
Chairman, CEO and Co-Founder
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David Chacko
Chief Financial Officer and Chief Business Officer
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Company data provided by crunchbase