Job Opportunity

Associate Director, Analytical R&D and QC

Location: San Diego, CA, US
Department: Technical Operations / CMC
Employment Type: Full Time
Reference Number: 2026100

Job Description Summary

The Associate Director, Analytical R&D and QC will be responsible for the analytical methodology, characterization, stability, and regulatory strategies for Mirati's pipeline of novel therapeutics directly targeting genetic and immunological drivers of cancer. He/She should have extensive experience in leading teams and overseeing analytical development activities for early-stage programs from pre-clinical through Phase 2. The successful candidate will be highly motivated to work within a science focused, collaborative, multidisciplinary environment to achieve the company's goals. The candidate should have an established track record of solving complex technical problems, excellent communication skills, leading and developing teams, and a major contributor on cross-functional teams.

Your Responsibilities

  • Work on multi-functional project teams to design and execute phase-appropriate analytical strategies for pre-clinical, Phase 1, and Phase 2 IND/IMPD Regulatory filings.
  • Manage the development, qualification, and validation of analytical methods with the ability to troubleshoot and optimize.
  • Establish phase-appropriate specifications and manage characterization of NCEs and reference standards, starting materials, process intermediates, drug substances, and drug products internally and across CDMOs.
  • Identify and recommend analytical methodologies to support chemical development, formulation development, and Quality Control.
  • Manage analytical activities at CROs/CDMOs including method development, validation, and characterization testing. Review analytical raw data packages and ensure studies are conducted in compliance with GLP and cGMP regulations, as applicable.
  • Resolve technical issues, review deviation events and failure investigations at contractor sites in coordination with internal and external quality control, quality assurance, and regulatory groups, as appropriate. Provide technical input for OOS and OOT investigations.
  • Author/review technical documents outlining analytical activities including method validation, reference standard and impurity characterization, stability, etc.
  • Author/review analytical sections of chemistry, manufacturing and control (CMC) sections of regulatory submissions.
  • Maintain up-to-date scientific knowledge through regular literature review and participation in conferences. Leverage knowledge to drive experimental design, data analysis and functional/cross-functional strategy development.
  • Represent analytical function in CMC teams and interdepartmental meetings.

What is Required

  • Doctoral (Ph.D.) degree in Analytical Chemistry or related discipline plus 8+ years of relevant industrial experience, or Masters (M.S.) +10 years or BS +15 years or more years' experience
  • Experience with analytical development (both drug substance and drug products) of small molecules and solid oral dosage forms in various stages of clinical
  • Extensive experience in analytical method development, troubleshooting, and investigations
  • In-depth experience with the development and validation of analytical methods (HPLC, GC, dissolution, compendial methods, etc.), identification of impurities and degradation products, and reference standard qualification.
  • Demonstrated knowledge of drug development, CMO management, manufacturing, and regulatory CMC for development and commercial stage programs
  • Working knowledge of GLP and cGMP, worldwide regulatory requirements, and current industry practices
  • Experience preparing and updating regulatory filings (IND, NDA, MAA)
  • Outstanding written and verbal communication skills
  • Ability to effectively organize and prioritize tasks to achieve established deadlines

About Mirati Therapeutics

Mirati Therapeutics is a late-stage biotechnology company whose mission is to discover, design and deliver breakthrough therapies to transform the lives of patients with cancer and their loved ones. The company is relentlessly focused on bringing forward therapies that address areas of high unmet need, including lung cancer, and advancing a pipeline of novel therapeutics targeting the genetic and immunological drivers of cancer. Mirati is using its scientific expertise to develop novel solutions in two registration-enabling programs: adagrasib (MRTX849), an investigational small molecule, potent and selective KRASG12C inhibitor, as monotherapy and in combination with other agents, and sitravatinib, an investigational spectrum-selective inhibitor of receptor tyrosine kinases in combination with checkpoint inhibitor therapies. Mirati is also advancing its differentiated preclinical portfolio, including MRTX1133, an investigational KRASG12D inhibitor, and other oncology discovery programs. Unified for patients, Mirati's vision is to unlock the science behind the promise of a life beyond cancer.


For more information about Mirati Therapeutics, visit us at Mirati.com or follow us on Twitter and LinkedIn. 


Why Join?

At Mirati, we have an unapologetic and relentless focus on our mission to transform the lives of patients with cancer and their loved ones. Patients and their families motivate us to work smarter, faster and better. We are driven by the knowledge that our efforts can one-day deliver life-saving therapies for the people who need us most. Urgency, open-mindedness, accountability and collaboration ground our work. These shared values are central to who we are, what we do and how we do it.


Our people fuel our success. They are fearless and passionate in their daily pursuit of our mission. We are committed to continuing to create a company and experience that attracts and keeps the best people. When you want your days to count and the work you do to matter, discovering and delivering potentially life-changing therapies is more than a job, it's the chance to be part of something bigger.

We believe diverse professional experiences and an inclusive culture can drive better outcomes for patients. We want employees to be authentic and use their perspectives to contribute to our mission in a meaningful way.

Mirati cultivates an environment where:

  • An entrepreneurial attitude is encouraged
  • Our people are empowered to speak up, embrace the gray and achieve solutions
  • Diverse experiences are an important of part making the best decisions
  • We laugh and have fun as a work family

No matter the role, we are unified by our passion for helping patients, and are inspired by a single vision - to unlock the science behind the promise of a life beyond cancer. Together, we own Mirati's success.

Learn more at Mirati.com/careers.

Mirati is an Equal Opportunity Employer (EOE) - we celebrate diverse experiences without regard to race, color, religion, creed, gender identity or expression, age, national origin or ancestry, citizenship, disability, sexual orientation, marital status, pregnancy, veteran status, membership in the uniformed services, genetic information, or any other basis protected by applicable law.

Notice to Third Party Agencies: Please note that Mirati Therapeutics Inc. does not accept unsolicited resumes from recruiters or employment agencies.