Director, QC and Stability
Department: Technical Operations / CMC
Employment Type: Full Time
Reference Number: 1708173
Job Description Summary
The position will oversee stability within the Technical Operations CMC department, and will report to the Head of Analytical Development. He/she will be responsible for the overall stability strategy as well as stability monitoring and data trending for development projects from pre-clinical through clinical development, registration filings and up to commercialization. He/she will provide guidance on the design of stability studies to support clinical studies and regulatory submissions. He/she will provide guidance and support to internal groups such as regulatory, quality and manufacturing as well as to outside groups such as contract manufacturing organizations to ensure that stability studies are conducted in compliance with all applicable regulations and corporate policies and procedures (GLP and GMP).
- Develop and recommend stability strategy and study design for drug substance and drug product
- Oversee stability testing for development, clinical and commercial materials
- Establish stability systems with the implementation of new SOPs and workflows, as well as stability tools (stability database, trending software, etc), to streamline stability operations.
- Oversee stability study design, execution, monitoring, reporting, data management (collection and archiving), and data trending and analysis for studies performed at contract service providers
- Provide leadership for stability deviation events, failure investigations, and temperature excursion reports
- Provide retest period/shelf life recommendations based on available stability data and statistical analysis in accordance with ICH guidelines
- Lead implementation of corrective actions and quality system improvements related to the stability program
- Analyze and present stability data at quarterly and ad hoc meetings. Author stability sections of regulatory filings.
- Participate in selection and audits of contract service providers used for stability studies
- 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
- Represent stability function in CMC teams and interdepartmental meetings
- Identify, manage and coordinate outsourcing activities when appropriate
- Ensure studies are conducted in compliance with GLP and GMP regulations, as applicable
- Assist with Product Quality Trending of release data to support process capability analysis and specification justification
What is Required
- Doctoral (Ph.D.) or Masters (M.S.) degree in Analytical Chemistry or related discipline plus 15 years of relevant industry experience, or BS +18 years of experience
- Successful history building and managing stability functions
- Hands-on experience managing stability studies at multiple sites (10+ years)
- Ability to independently design, conduct and interpret laboratory studies
- Experience writing stability sections of regulatory filings (IND, NDA, MAA)
- Strong 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 25% 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 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.