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Assoc Director or Director, Pharmaceutical Development

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 Associate Director / Director of Pharmaceutical Development will be a liaison for the manufacture of Erasca’s small molecule development drug products (DPs) at external contract development and manufacturing organizations (CDMOs). This individual will work in a cross functional team environment with colleagues from process development, analytical, formulation development, supply chain, QA, and regulatory CMC to plan, coordinate, and execute internal and external DP development and manufacturing activities.

Essential Duties and Responsibilities:  

  • Provide scientific, technical, and strategic direction to the design, development, and manufacture of investigational drug products from pre-clinical/clinical to commercial stage.
  • Manage activities and contractual relationship with contract manufacturers and laboratories performing product/formulation development, manufacturing, analytical development and testing, stability, and validation services.
  • Lead and collaborate with cross functional project team members to meet CMC goals.
  • Represent CMC DP and provide strategic recommendations and status reporting to cross-functional program team.
  • Author, review, and/or approve development reports, regulatory submissions (e.g., IND, IMPD, NDA, MAA), and SOPs.
  • Build internal and external capabilities to support rapid progression of programs and ensure data generation per regulatory requirements.
  • Act as Subject Matter Expert for knowledge of GMP regulations, ICH guidance, and current regulatory expectations regarding DP manufacture and process control.
  • Manage CMC DP program budget within the framework of an internal and outsourced development and manufacturing business model.
  • Perform all duties in keeping with the Company’s core values, policies and all applicable regulations.

Required Education and Experience: 

  • MS/PhD degree or equivalent in Pharmaceutics, Chemistry, or related field.
  • 8 to 10+ years of progressive experience in the Biotech or Pharmaceutical industry focused on small molecule drug product development and manufacturing (experience in a late phase manufacturing environment is preferred).
  • Experience working with contract manufacturing organization including a working knowledge of small molecule drug product validation and experience with regulatory submissions.
  • Established and demonstrated project management skills (good working knowledge of Project a plus).
  • Strong written and verbal communication and interpersonal skills.
  • Hands-on individual with a collaborative personal style and the ability to work well in a fast-moving team/collaborative environment.
  • A strong track record of scientific achievement.
  • Demonstrated ability to influence without direct control.
  • Familiarity with ICH guidelines and regulatory expectations relevant to drug 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.

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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