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Sr Director, Biologics Pharmaceutical Sciences

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: 

The Senior Director of Biologics Pharmaceutical Sciences will be accountable for establishing the biologics CMC development plan and leading the execution of the plan for drug substances and drug products from pre-clinical through commercial process implementationThe successful candidate will have a strong technical understanding of CMC activities for antibodies, including upstream and downstream process development, formulation, analytical, and manufacturing, as well as direct experience with regulatory submissions.

Essential Duties and Responsibilities: 

  • Define a biologics CMC strategy that best supports Erasca’s portfolio needs. 
  • Evaluate and negotiate with Contract Manufacturing Organizations (CMOs) and provide oversight of activities at these partners by working with expert consultants. 
  • Manage timelines and budgets for manufacturing and CMC activities for biologics. 
  • Review and approve master and executed batch records from all manufacturing activities including analytical release testing, stability studies, and investigations, as required. 
  • Work with cross functional team to deliver biologics CMC objectives to support overall program development and registration strategy. 
  • Identify and communicate risks and implement effective mitigation strategies. 
  • Act as Subject Matter Expert for knowledge of GMP regulations, ICH guidance, and current regulatory expectations regarding DS and DP development and control. 
  • Author, review, and/or approve development reports, regulatory CTD sectionsand quality procedures. 
  • Serve as subject matter expert for any business development diligence activities. 
  • As a member of the Pharmaceutical Development & Operations leadership team, contribute to the direction and performance of the organization. 
  • Perform all duties in keeping with the Company’s core values, policies and all applicable regulations. 

Required Education and Experience:

  • PhD from a leading institute in Biochemistry, Molecular Biology, Pharmaceutical ChemistryProtein Chemistry, Chemical Engineering, or related field. 
  • 10+ years of progressive experience the biologics and/or antibody manufacturing or process development in a GMP environment. 
  • A strong track record of scientific achievement and technical development for biological therapeutics.  
  • Demonstrated ability to influence without direct control. 
  • Familiarity with ICH guidelines and regulatory expectations relevant to biologics development and cGMPs including regulations in multiple countries. 
  • Demonstrated project, people, and budget management experience. 
  • Excellent communication and interpersonal skills. 
  • Excellent team player able to build and sustain organizational respect and trust at all levels. 
  • Proven track record working with CMOs, including selection, negotiation, initialization, and oversight. 
  • 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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