Sr Principal Scientist, Product Development
Department: Technical Operations / CMC
Employment Type: Full Time
Reference Number: 1982922
Job Description Summary
The Sr. Principal Scientist, Product Development will be responsible for design and development of small molecule drug products, including injectables, for toxicological assessments, clinical studies and commercialization. You will provide technical expertise towards characterization of the physicochemical characterization of the new molecular entities (NCEs), preformulation assessments, and formulation development. The scope includes assessment of external proprietary and non-proprietary drug delivery technologies that could be suitable for enabling clinical studies and can be further developed for commercialization. You will work effectively with cross-functional groups, including analytical development, process chemistry, clinical, quality and regulatory, to ensure that all preformulation and product development activities in compliance with all applicable regulations and corporate procedures (GxP, ICH). You will serve as a subject matter expert in activities related to preformulation, formulation and drug delivery approaches for compound enablement.
- Own preformulation and formulation development activities internally or at external contract research organizations.
- Design effective strategies for developing drug product via conventional methods or drug delivery & process technology approaches. Scope includes oral solid dosage forms as well as parenterals.
- Engage with discovery research teams for biopharmaceutics assessment of NCE's and pharmaceutical candidate optimization (PCO) activities. Support preclinical & clinical teams in the production of optimal formulations and preparation procedures for toxicology, DMPK studies and clinical trials.
- Conduct / coordinate formulation feasibility assessments, technology selection and product development activities at internal sites or external partner firms. Design and implement efficient DOE's to support formulation & process robustness (e.g. optimization of pH, excipient levels, stabilizers).
- Engage with API process chemistry and material science teams to ensure drug substance with optimal physico-chemical properties is advanced to product development. Support material characterization efforts - solid state form, mechanical attributes, particle size assessment, physicochemical stability, etc.
- Author / review drug product manufacturing batch records, study protocols, and relevant sections of regulatory documents (e.g. IND, IB, NDA). Author / coordinate preparation of high-quality technical reports and integrated project summaries.
- Maintain up-to-date scientific knowledge through regular literature review and participation in conferences.
What is Required
- Doctorate (Ph.D.) or Masters (M.S.) degree in Pharmaceutics, Pharmaceutical Science, Pharmaceutical Chemistry or a related discipline, with 8+ years of relevant industry experience, or BS with 20+ years of relevant experience.
- High competency in preformulation, biopharmaceutics and physicochemical characterization aspects pertinent to drug product development. Experience working with discovery chemistry teams for pharmaceutical candidate optimization and developability assessments.
- In-depth knowledge of proprietary and non-proprietary formulation and process technologies for small-molecule compound enablement (solids, liquids and parenterals).
- Adept in material characterization technologies including x-ray diffractometry, spectroscopy, dynamic vapor sorption and thermal analysis.
- Ability to independently design and implement study plans related to drug product & process development at internal or external CDMO sites.
- Capability to adapt and improvise based on real time results and findings. Exceptional written and verbal communication skills.
- Experience in authoring and review of regulatory submissions (e.g. IND, IB), batch records, protocols and associated development reports.
- Strong understanding of ICH, cGMP, worldwide regulatory requirements and current industry best practices.
- Ability to travel up to 25% domestically and internationally.
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.