Associate Director, Chemical Development
Department: Technical Operations / CMC
Employment Type: Full Time
Reference Number: 1597918
Job Description Summary
The Associate Director, Chemical Development will report to the Director Chemical Process R&D and be responsible for the development and implementation of practical/robust synthetic processes and controls to support small molecule programs with the goal of delivering preclinical and clinical drug substances meeting program needs. Individual will be responsible accountable for defining and developing synthetic processes that comply with regulatory requirements and manufacture API to support clinical trials, registrational and commercial batches.
- Work with multi-functional project teams to define API requirement and supply strategy
- Work closely with cross functional teams to ensure seamless transitions between drug substance and drug product programs and suppliers
- Build appropriate risk management strategies for chemical development and manufacturing
- Responsible for phase appropriate synthesis route design, practical implementation of synthesis processes and controls for regulatory starting materials, intermediates and drug substances for research and development programs
- Conduct API synthetic route design, scouting and process development and manufacturing, tech-transfer and manufacturing at CROs or CMOs.
- Critical review of proposals from CROs or CMOs; perform appropriate due diligence as needed to ensure CROs and CMOs can support the requirements of individual chemical development programs effectively
- Directly lead and manage CMO activities, provide technical supervision and guidance. Provide manufacturing oversight for the production of drug substance.
- Resolve technical issues or deviations in coordination with internal and external quality control, quality assurance, and regulatory groups
- Facilitate and enable quick problem solving
- Implementation of risk-based approach to development, QbD and DoE principles at appropriate development stages
- 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, qualification and validation of starting material, intermediate or API processes as needed
- Support PAR studies and pre-validation and validation activities for drug substance
- Write, review and approve study protocols. Approve manufacturing batch records, compose developmental and campaign reports and maintain relevant CMC files, reports and data packages.
- Provide scientific update to cross-functional teams
- Draft and review regulatory sections in support of CMC submissions.
- Maintain up-to-date scientific knowledge through regular literature review and participation in conferences. Leverage external data and publications and relevant industry benchmarking information to drive experimental design, data analysis and functional/cross-functional strategy development
- Participate in an interactive, highly collaborative, team-oriented culture, interfacing primarily with the discovery functions and the CMC team
- Participate in, propose and run departmental initiatives aimed at improving our work-practices.
What is Required:
- Doctoral (Ph.D.) degree (or M.S. with equivalent experience) in Chemistry, Chemical Engineering or related discipline with a minimum of 8 years of relevant industrial experience.
- Hands-on experience in non-GMP, GMP API process development, scale up and manufacturing
- Demonstrated knowledge of drug development, CMO management, manufacturing, supply chain management and regulatory CMC.
- Working knowledge of current Good Manufacturing Practices (cGMP).
- Proven ability to develop and implement strategic plans.
- Demonstrated competencies in a core CMC discipline such as drug substance process development and manufacturing.
- Proven problem-solving skills are a must.
- Must possess the ability to effectively manage multiple projects to achieve established deadlines.
- Ability to adapt rapidly and change focus based on real time results and findings.
- Outstanding written and verbal communication skills with a demonstrated ability to communicate complex ideas with clarity.
- Ability to travel up to 30% 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 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.