career opportunities

Currentjob openings

Assoc Director or Director, Process Development & Manufacturing

San Diego, CA or remote

Erasca is a San Diego based biotechnology company focused on discovering and developing precision medicines for the benefit of patients with cancer. We are advancing multiple programs targeting biological drivers of cancer and are pursuing additional pipeline expansion opportunities through academic and biopharmaceutical collaborations. Our programs, currently focused on innovative discovery research, take novel approaches to shutting down certain oncogene drivers of solid tumor malignancies. 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 Sr Director Process Development & Manufacturing (PDM), the Associate Director or Director of Process Development & Manufacturing will be responsible for the design, development, and implementation of robust synthetic processes to support small molecule programs with the goal of delivering preclinical and clinical drug substance batches meeting program needs.  

Essential Duties and Responsibilities:  

  • 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, intermediates, and API processes between sites as needed  
  • Collaborate with medicinal chemistry team during lead optimization and candidate selection phases 
  • Perform phase appropriate process R&D to support both early and late-stage programs 
  • Perform fate and purge studies, mutagenic 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 
  • Work closely with cross functional teams to ensure seamless transitions between drug substance and drug product programs and vendors 
  • Critical review of proposals from CMOs and CROs; perform appropriate due diligence as needed to ensure CMOs and CROs 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 
  • Function as a highly effective communicator and team player in a dynamic team culture 
  • 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, minimum of 10 years of industry experience in developing small molecule pharmaceuticals 
  • Laboratory experience required 
  • Hands-on experience with different stages of drug substance development 
  • 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 in clinical and/or commercial manufacturing 
  • Experience in managing and overseeing development and manufacturing activities at CMOs and CROs 
  • Ability to build strong relationships with co-workers of various backgrounds and expertise 
  • Ability to function at a high level in a team setting whether as manager, lead scientist, or individual contributor 
  • Demonstrated ability to achieve high performance goals and meet deadlines in a fast-paced environment  
  • Effective interpersonal and communication skills; must be a collaborative team player with a can-do attitude 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.

Apply for this Job

* - required fields