Job Opportunity

Scientist I-Data Review, Analytical Development 2

Location: San Diego, CA, US
Department: Technical Operations / CMC
Employment Type: Full Time
Reference Number: 2071850

Job Description Summary

The individual will be responsible for the review of any documentation associated with the release and stability data of drug substance and drug product. He/she will provide support for GMP data review of clinical, registration, and commercial batches, as well as GLP data review of batches used in GLP toxicology studies.

Your Responsibilities

  • Review all raw data (notebooks and chromatograms) for adherence to methods and testing protocols. Communicate any deficiencies to the laboratory and partner to resolve any issues.
  • Review CoAs and stability reports for completeness and correct information compared to the raw data.
  • Post CoAs and populate trackers internally as appropriate.
  • Trend and track the data to highlight during review if there are any OOT results or any significant changes observed during stability studies that have not been already noted.

Hybrid role - can work from home a few days and be in the office a few days a week.

What is Required

  • Bachelor's or master's degree in chemistry or science degree with 3-5 years of Quality Control Laboratory experience. Minimum 2 years of experience with QC and stability in pharmaceutical industry is required.
  • Understanding of Phase-appropriate GMP requirements, SOP and pharmacopeia guidance including USP, EP, ICH and FDA guidance
  • Experience with analytical development and stability (both drug substance and drug products) of small molecules and solid oral dosage forms in various stages of development (preclinical though commercial)
  • Working knowledge of GLP and cGMP, worldwide regulatory requirements, and current industry practices
  • Outstanding written and verbal communication skills
  • Ability to effectively organize and prioritize tasks to achieve established deadlines
  • Ability to multi-task and adapt rapidly to changing business requirements in a dynamic corporate environment.
  • Proven problem-solving skills are a must
  • Ability to travel up to 10% domestically and internationally
  • This position is based at our Cray court site, hybrid and remotely is considered.

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.