Senior Manager, Reference Standards Analytical Development
Department: Technical Operations / CMC
Employment Type: Full Time
Reference Number: 1704241
Job Description Summary
This position will be responsible for the sourcing, characterization, inventory, maintenance, and shipment of reference standards and markers in support of activities for new drug substances and new drug products. He/she will endure that reference materials are synthesized and characterized to support analytical activities (testing, method validation, etc) in compliance with applicable guidelines and procedures for clinical, registrational, and commercial batches.
- Maintain the reference standard inventory and ensure that materials are retested at regular intervals.
- Review reference standard documentation, including reference standard COAs and characterization reports.
- Work with Chemical Development to coordinate the sourcing of new reference standard materials within project timelines.
- Establish workflows and procedures to standardize reference standard activities.
- Develop plan for introduction of new reference standard lots.
- Coordinate shipment of reference standards between sites.
- Manage analytical activities at CROs/CMOs related to characterization testing and retest of reference standards. Review analytical raw data packages. Ensure studies are conducted in compliance with GLP and cGMP regulations, as applicable.
- Provide technical support in resolving technical issues, reviewing deviation events and failure investigations at contractor sites in coordination with internal and external. quality control, quality assurance, and regulatory groups, as appropriate. Provide technical input for OOS and OOT investigations.
- Provide support in authoring or review of analytical sections of chemistry, manufacturing and control (CMC) sections of regulatory submissions, as needed.
- 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 analytical function in CMC teams and interdepartmental meetings.
What is Required
- Doctoral (Ph.D.) or Masters (M.S.) degree in Analytical Chemistry or related discipline plus 5+ years of relevant industry experience, or BS +8 or more years' experience
- Experience with analytical development of small molecules and solid oral dosage forms in various stages of development (preclinical to Phase 3)
- Experience with reference standard qualification and the identification of impurities and degradation products.
- Extensive hands-on experience of CMO management for analytical projects.
- Working knowledge of GLP and cGMP, worldwide regulatory requirements, and current industry practices
- Outstanding 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.