Scientific Director, Chemical Process R&D
Department: Technical Operations / CMC
Employment Type: Full Time
Reference Number: 1836710
Job Description Summary
The Scientific Director of Chemical Development will report to the head of Chemical Process R&D will be responsible for the design, development and implementation of robust synthetic processes to support Mirati's small molecule programs with the goal of delivering preclinical and clinical drug substance batches meeting program needs. Individual will be accountable for implementing phase appropriate strategies to develop synthetic processes that comply with regulatory requirements and manufacture API to support clinical trials, registrational and commercial batches. Specific responsibilities will also include but are not limited to the following; managing drug substance development, managing timelines for development and manufacturing activities performed at CDMOs, coordinating material shipments, assisting in cGMP vendor quality audits, maintaining all relevant files and reports required for regulatory submissions/health authority inspections/due diligence, and the authoring of the CMC sections of regulatory health authority submissions.
- Will directly lead and manage CMO activities.
- Direct chemical process development activities for one primary program and contribute to all development programs as needed.
- Provide manufacturing oversight to produce drug substance.
- Regulatory writing to support CMC submissions.
- Manage Chemical Development team to deliver a robust chemical synthesis process for research and development programs
- Responsible for phase appropriate synthesis route design, practical implementation of chemical processes and controls for regulatory starting materials, intermediates and drug substances
- Lead fate and tolerance studies, genotoxic impurity evaluation and establish the framework of for the control strategy of the drug substance from early development with a long-term vision of the commercial process
- Lead/Support technical transfer of starting material, intermediate or API processes between sites as needed
- Work closely with cross functional teams to ensure seamless transitions between drug substance and drug product programs and vendors
- Ability to coordinate with internal and external quality control, quality assurance, and regulatory personnel to resolve technical issues or deviations
- Participate in an interactive, team-oriented culture, interfacing primarily with the discovery functions and the CMC team
- Critical review of proposals from CROs or CMOs; perform appropriate due diligence as needed to ensure CROs and CMOs can effectively support the requirements of individual chemical development programs
- Implementation of risk-based approach to development, QbD and DoE principles at appropriate development stages
- Lead/Support DOE/PAR/NOR studies and pre-validation and validation activities for drug substance
- Author, review, and adjudicate relevant CMC sections for US and ex-US regulatory filings as needed
- Build appropriate risk management strategies for chemical development and manufacturing
- Up to 25% travel will be needed for scientific project management and monitoring of critical project activities
What is Required
PhD or MS with >10 years of experience in organic chemistry, chemical engineering, related discipline with relevant drug substance development experience.
- Knowledge of current Good Manufacturing Practices (cGMP).
- Demonstrated knowledge of drug development, CMO management, manufacturing, supply chain management and regulatory CMC.
- Proven ability to develop and implement strategic plans.
- Ability to effectively organize and prioritize tasks to achieve established deadlines.
- Demonstrated competencies in a core CMC discipline such as drug substance process development and drug substance manufacturing.
- Excellent troubleshooting and problem-solving skills are a must.
- Experience leading teams.
- Must possess the ability to effectively manage multiple projects.
- Ability to adapt rapidly and change focus based on real time results and findings.
- Exceptional interpersonal, written and verbal communication skills.
- Experience with authoring regulatory documents for IND and NDA filings for new chemical entities.
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 KRAS G12C 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 KRAS G12D 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.