Sr. Scientist, Analytical R&D
Department: Technical Operations / CMC
Employment Type: Full Time
Reference Number: 2522664
Job Description Summary
The Sr. Scientist, Analytical R&D will report to Director, Analytical R&D. In this role, the Sr. Scientist will serve as internal expert of Analytical investigation/development and provide oversight and management of investigation and development activities at vendors. This role will also collaborate with Chemical Development and Product Development.
- Development, pre-validation and troubleshooting of analytical test methods for drug substances (small molecules), raw materials, process intermediates, and drug products (capsules, tablets)
- Closely collaborate with Chemical Development and Product Development during development
- Perform excipient compatibility and stability studies to aid with formulation selection
- Independently design and conduct analytical experiments
- Implement new experimental protocols/techniques
- Evaluate data and summarize in associated reports and documentation
- Understand relevant scientific literature and apply theoretical framework to solving problems within scientific discipline in a timely manner
- Interact with cross-functional teams with internal and external team members from various functional departments including Chemical Development, Product Development, Quality Assurance, and Regulatory
- Manage activities related to analytical method development, optimization, troubleshooting, qualification, and validation activities for starting materials, process intermediates, drug substances, and drug products internally and across CMOs
- Provide support in identifying and recommending analytical methodologies to support chemical development, formulation development, QC and stability testing.
- Manage when appropriate analytical activities at CROs/CMOs including method development and qualification/validation, characterization testing. Review of analytical raw data packages. Ensure studies are conducted in compliance with GLP and cGMP regulations, as applicable.
- Provide technical support in resolving technical issues, reviewing 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
What is Required
- Bachelor (BS) degree with 10 or more years relevant experience, or Masters (M.S.) degree in Analytical Chemistry or related discipline with 8 years relevant experience, or Doctoral (Ph.D.) degree in Analytical Chemistry or related discipline with 1-3 years relevant experience.
- Experience with analytical development of small molecules and solid oral dosage forms in various stages of development (preclinical to Phase 3, with an emphasis on late stage development)
- Extensive analytical method development, troubleshooting, and validation experience
- In-depth experience with the development and validation of analytical methods (HPLC, GC, dissolution, compendial methods, etc.), identification of impurities and degradation products, and physical characterization (e.g. XRPD, PSD).
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.