Assoc Director/Director, Pharmaceutical Development

Erasca•South San Francisco, CA

2d•$200,000 - $225,000

About The Position

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 the Sr Director Pharmaceutical Development, the Associate Director or 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 on cross functional teams 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.

Requirements

Advanced degree in Pharmaceutics, Chemistry or related field is highly preferred, equivalent work experience and scientific credibility may be considered.
10 to 12+ years of progressive experience in the Biotech or Pharmaceutical industry focused on small molecule drug product development and manufacturing, experience in enabling technologies and solid oral dosage form manufacturing preferred.
Experience managing relationships with contract manufacturing organizations including knowledge of small molecule drug product validation and experience with regulatory submissions.
Familiarity with ICH guidelines and regulatory expectations relevant to drug development and cGMPs including regulations in multiple countries.
A strong track record of scientific achievement.
Demonstrated ability to influence without direct control.
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; 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 commitment to science and patients.

Nice To Haves

experience in enabling technologies and solid oral dosage form manufacturing preferred.

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.
Act as Subject Matter Expert for knowledge of GMP regulations, ICH guidance, and current regulatory expectations regarding DP manufacture and process control.
Function as a highly effective communicator and team player in a dynamic team culture.
Perform all duties in keeping with the Company’s core values, policies and all applicable regulations.