Sr Research Scientist, Preformulation
Department: Technical Operations / CMC
Employment Type: Full Time
Reference Number: 1990475
Job Description Summary
The Sr. Research Scientist Preformulation, will be responsible for laboratory and technical activities related to biopharmaceutical assessment of candidate new chemical entities (NCE's), establish their suitability for product development, and progression to early-stage clinical trials. The individual will be responsible for API polymorph and salt characterization, developing formulations for toxicology and PK/PD assessment, and exploring formulation & process approaches to enhance product performance.
- Evaluate/characterize the physicochemical properties (pKa, LogP, LogD, dissolution/solubility), solution and solid stability, hygroscopicity, crystallinity, mechanical characteristics, thermal properties of drug candidates and assess developability risks.
- Collaborate with internal as well as external teams to conduct polymorph screening and salt selection of API candidates, identify and recommend appropriate solid form for drug product development.
- Develop preclinical formulations to enhance oral bioavailability and to support PK/PD and toxicology studies.
- Explore drug product formulation options for IND candidates internally, and as needed, by working with external CDMOs and technology partners.
- Generate high quality data based on sound scientific principles and prepare data summaries, technical reports, scientific presentations, and regulatory documents.
- Collaborate with internal and external stakeholders to support project plans and schedules ensuring that tasks are executed in accordance with operational plans, cGMP requirements and regulatory commitments.
What is Required
- Ph.D. degree in pharmaceutical sciences, physical chemistry, or related a scientific discipline with 3+ years of experience, or M.S. degree with 5+ years of experience in pharmaceutical industry related to preformulation or early-stage formulation development.
- Role will be based at Company HQ site in San Diego and requires COVID-19 vaccination or weekly negative COVID-19 test results
- Experience with techniques and instruments for determining the physicochemical properties of drug substances, such as DSC, TGA, PXRD, KF, FTIR, and HPLC.
- Strong understanding of common bioavailability enhancing technologies such as spray-dried dispersions, nano-particulates, lipid systems and complexation. Hands-on experience with multiple drug-enabling technologies is preferred.
- Robust knowledge of pharmaceutical principals governing stability and performance of API and drug products, including thermodynamic and kinetic factors.
- Demonstrated ability to work effectively in a fast-paced and team-oriented environment.
- Must be well organized, proactive, adaptable, and detail oriented.
- Strong interpersonal, communication, and collaboration skills.
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.
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.