Senior Director, Chemical Process R&D
Department: Technical Operations / CMC
Employment Type: Full Time
Reference Number: 1836710
Job Description Summary
The individual will oversee and direct all chemical process research and development and provide technical oversight of the supply of small molecule drug substance (API) for all Mirati development projects supporting pre-clinical lead candidate selection through registration and commercialization. Process research and development is conducted internally and externally, and all GMP manufacturing activities are executed in partnership with contract development and manufacturing organizations (CDMO). He/she will provide guidance and support to internal groups such as business development, marketing, pharmaceutical and analytical development, regulatory, quality, manufacturing and supply chain as well as to outside groups such as contract manufacturing organizations to ensure that products are manufactured in compliance with all applicable regulations and corporate policies and procedures (GLP and GMP). He/she will provide strategic input and risk assessments and oversee preparation of CMC regulatory submissions and interact with regulatory agencies. Ideal candidates will have significant experience with process R&D and GMP manufacturing combined with exceptional project leadership, organizational, and communication skills. He/she will select, develop and evaluate personnel to ensure the efficient operation of the function.
- Develop and recommend chemical development and manufacturing strategies
- Lead technical execution of defined strategies for process research and route development, process development and scale-up, definition of process controls and technology transfer
- Direct chemical development, optimization, qualification, and validation API manufacturing
- Responsible for development and implementation of chemical process R&D function and organization
- Works closely with Legal function on key aspects and strategy for Mirati Intellectual Property
- Identify suppliers for starting materials and intermediates, and develop plans for consistent and continuous supply
- Ensure timely completion of high-quality technical reports/protocols and integrated cross-functional reports and/or strategy documents. Primary author and/or reviewer for analytical sections of regulatory submissions and/or briefing documents to support clinical development
- Supply drug substance and/or metabolites of drug substance with stable or radiolabels as needed for analytical development, non-clinical studies, and clinical protocols
- Represent chemical development at CMC meetings to provide assessments, evaluations, status, issues, and other relevant technical aspects of the corresponding program
- Provides leadership for deviation events or failure investigations at contractor sites. Leads implementation of corrective actions and quality system improvements
- 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
- Lead or participate cross-functional collaborations with analytical/product development and supply chain operations to define integrated product control strategies and support drug substance/drug product development/manufacturing
- Represent department and present work at interdepartmental meetings
- Identify, manage and coordinate outsourcing activities when appropriate
- Serve as primary liaison with outside vendors on projects
- Provides recommendations and input on departmental policies, new product opportunities, product developmental strategies, procedures, resourcing, budgets, goals and objectives. Assist and advise the Technical Operations Leadership as required
What is Required
- Doctoral (Ph.D.) or Masters (M.S.) degree in Chemistry, Chemical Engineering or related discipline plus 13 years of relevant industrial experience, or BS +18 or more years' experience
- Expertise in process research and development of small molecule pharmaceutical ingredients
- Advanced knowledge of drug development, CRO/CDMO management, manufacturing and regulatory CMC for development and commercial stage programs
- Management experience (12+ years) with GLP and cGMPs, worldwide regulatory requirements and current industry practices
- Late stage API experience with DoE, QbD, FMEAs and process validation to enable filing of an NDA
- Extensive experience preparing and maintaining regulatory filings (IND, NDA, MAA)
- Organized and able to build and lead a functional group of high-level individual contributors, and cross-functional teams, utilizing solid interpersonal and team skills
- Successful history building and managing chemical development functions
- Exceptional written and verbal communication skills
- Ability to effectively organize and prioritize tasks to achieve established deadlines
- Ability to multi-task and good adapt rapidly to changing business requirements in a dynamic corporate environment
- Proven problem-solving skills are a must
- 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.