Associate Scientific Director, Formulation Development
Department: Technical Operations / CMC
Employment Type: Full Time
Reference Number: 2430682
Job Description Summary
The Associate Scientific Director will be responsible for parenteral formulation and process development of Mirati's new chemical entities (NCEs) utilizing internal laboratories and external resources. The individual will be responsible for conducting targeted preformulation studies, preparing pre-clinical formulations for toxicology and PK assessments, and developing product for first-in-human (FIH) and early-stage clinical studies. The incumbent will engage in developments, tech-transfer activities and GMP manufactures of clinical trial materials (CTMs) at contract development and manufacturing organizations (CDMOs).
- Plan and conduct research studies to support preformulation, formulation, and process developments of injectable dosage forms for early-stage clinical studies (first-in-human, Phase I-II).
- Design prototype formulations and manufacturing processes, conduct in-house experiments, and transfer such technology to CDMO/CMO for manufacturing CTM.
- Develop and prepare in-house pre-clinical formulations to enable PK/PD and toxicology studies.
- Manage program activities with key suppliers and external manufacturing partners including coordination, communication, and technical oversight to ensure timely execution of deliverables.
- 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
- PhD. degree in Pharmaceutical Sciences or related a scientific discipline with 10+ years of experience, or M.S. degree with 15+ years of experience in pharmaceutical industry related to formulation and process development.
- Expertise in parenteral dosage form development of small molecules for early clinical studies of first-in-human (FIH) and Phase I/II is required. Added experience with oral drug product platforms is a plus.
- Hands on experience in parenteral formulation development utilizing one or more complex injectable drug delivery technologies such as liposome, nanoparticle albumin bound (nab), lipid microspheres, phospholipid gel, emulsion, suspension and lyophilization of injectable drug products is required.
- Ability to interpret the preformulation data package to understand the physicochemical properties of drug, drug solubilization, chemical degradation and physicochemical stability of drug substance and drug products.
- Robust understanding of formulation and process development aspects (e.g. DOE experiments) and scaleup activities for manufacturing GMP clinical supplies.
- Knowledgeable in operating principles and troubleshooting of equipment required for manufacturing sterile injectable drug products.
- Demonstrated ability to work effectively in a fast-paced and team-oriented environment.
- Must be well organized, proactive, and detail oriented.
- Ability to multi-task and work efficiently in an agile environment.
- Strong interpersonal, communication, and collaboration skills along with strengths in delivering results on-time.
- Ability to travel up to 25% domestically and internationally.
- Role will be based at Company HQ site in San Diego and requires COVID-19 vaccination or weekly negative COVID-19 test result.
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.