Director, Process Technology - Late Stage Process Development
Department: Technical Operations / CMC
Employment Type: Full Time
Reference Number: 1649711
Job Description Summary
- Director, Process Technology will report to the head of Chemical Process R&D and will be responsible for the establishment of the process technology center to support chemical process R&D activities at Mirati Therapeutics. Individual will be responsible for establishing and implementing process technology with emphasis on solid state science, reaction engineering/safety, new technologies such as flow chemistry, HTE in catalysis and bio-catalysis, supporting development of chemical processes for manufacturing of drug substances that comply with regulatory, clinical, registrational and commercial requirements.
- Specific responsibilities will include but are not limited to the following: establish process technology center to enable capability in material science, crystallization process development, reaction safety evaluation and engineering studies with ultimate goal to support all chemical process R&D activities in drug development; tech transfer of viable processes to CROs and CDMOs and ensure effective executions; help authoring all relevant files and reports required for regulatory submissions/health authority inspections/due diligence, and CMC sections of regulatory health authority submissions; build high performance R&D team
- Define and develop strategy to establish process technology capability at Mirati Therapeutics
- Establish expertise in material science, crystallization and particle technology; Define and optimize the physical and particle properties of drug substances and contribute to the selection of a suitable dosage form for optimal and consistent drug product performance.
- Establish technical capability in reaction engineering and safety study, HTE in catalysis, flow chemistry and bio-catalysis.
- Build and manage process technology group to deliver robust chemical processes for small molecule programs.
- Provide technical support to activities related to drug substance production at CRO/CDMOs.
- Provide manufacturing oversight for the production of drug substance as needed
- CMC Regulatory writings to support regulatory submissions.
- Responsible for phase appropriate chemical process design, development, and implementation
- Lead/support technical transfer of starting material, intermediate or API processes between production sites.
- Work closely with cross functional teams to ensure seamless transitions between drug substance and drug product projects and suppliers.
- Participate in an interactive, team oriented culture, interfacing primarily with the CMC team.
- 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 program effectively.
- Implementation of risk based approach to development, QbD and DoE principles at appropriate development stages.
- Support PAR 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 >10-15 years of experience in material science, physical organic chemistry, chemical engineering, and related discipline with relevant drug substance development experience in pharmaceutical and biopharmaceutical industries.
- Knowledge of current Good Manufacturing Practices (cGMP).
- Demonstrated knowledge of drug development, tech transfer, CMO management, manufacturing, 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, drug product pre-formulation development, drug substance manufacturing.
- Proven problem-solving skills are a must.
- Must possess the ability to effectively manage multiple projects and build high performance team.
- Ability to adapt rapidly and change focus based on real time results and findings.
- Exceptional written and verbal communication skills.
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.