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Sr Scientist, Process Development & Manufacturing

San Francisco Bay Area, CA

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 Senior Director, Process Development and Manufacturing, the Senior ScientistProcess Development and Manufacturing will be responsible for the design and execution of experiments to support process development and will provide technical oversight of contract development and manufacturing organizations (CDMOs) for small molecule programs ranging from research phase to clinical development and eventually commercial production.  The Senior Scientist will also take a drug substance lead role on one or more programs and manage projects independently.  

Essential Duties and Responsibilities:  

  • Plan and execute experiments that support process development activities and project goals 
  • Maintain safe working environment and EHS compliance. 
  • Identify reactions and processes that are not suitable for scaleup and address those issues with alternate approaches. 
  • Design, develop and implement robust chemical synthesis processes for starting materials, intermediates and APIs for research and development programs. 
  • Support technical transfer of starting material, intermediate and API processes between manufacturing sites as needed. 
  • Manage drug substance process research activities of external scientists at CDMOs. 
  • Perform phase appropriate process R&D to support both early stage and late stage programs. 
  • Perform fate and tolerance studies, genotoxic impurity evaluation and establish the framework for the control strategy of the drug substance from early development with a long-term vision of the commercial process. 
  • Maintain high level of expertise through familiarity with scientific literature and by attending scientific trainings, conferences and courses. 
  • Critical review of proposals from CDMOs; perform appropriate due diligence as needed to ensure CDMOs can support the requirements of individual chemical development programs effectively. 
  • Support PAR studies and pre-validation and validation activities for drug substance. 
  • Author relevant CMC sections for US and ex-US regulatory filings as needed. 
  • Up to 25% travel will be needed for scientific project management and monitoring of critical project activities. 
  • Perform all duties in keeping with the Company’s core values, policies and all applicable regulations. 

Required Education, Experience and Attributes:  

  • PhD in synthetic organic chemistry with a minimum of 5 years of industry experience developing small molecule pharmaceuticals or BS/MS degree with minimum of 10 years of industry experience developing small molecule pharmaceuticals. 
  • Laboratory experience in synthetic organic chemistry and small molecule process development required. 
  • Chemical development experience with synthesis and crystallizations of chiral molecules preferred. 
  • Thorough understanding of the synthetic and analytical techniques necessary for proper polymorph screening, optimization and patent protection. 
  • Thorough understanding of cGMP, ISO and ICH guidelines and industry best practices. 
  • Experience and understanding of Design of Experiments (DOE) and Quality by Design (QbD) principles. 
  • Experience managing and overseeing development and manufacturing activities at CDMOs. 
  • Ability to build strong relationships with co-workers of various backgrounds and expertise; flexibility and integrity are both paramount. 
  • Values-based leadership that is guided by Erasca’s Core Values. 
  • Ability to function at a high level in a team setting whether as manager, lead scientistor individual contributor. 
  • Demonstrated ability to achieve high performance goals and meet deadlines in a fast-paced environment. 
  • Effective interpersonal and communication skills; a collaborative team player with a can-do attitude, desire to pitch in where and when needed, and the ability to identify and implement creative solutions to complex technical problems. 
  • Strong learning orientation, curiosity, and passion for science and patients.  

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.

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