Associate Director, Analytical Quality Assurance
Department: Regulatory CMO/ Clinical
Employment Type: Full Time
Reference Number: 2081279
Job Description Summary
Reporting directly to the Director, Analytical Quality Assurance, the Associate Director, Analytical Quality Assurance will be responsible for the quality oversight and management of GMP-analytical-related activities, the quality management of contracted testing vendors, and strategies to advance overall company quality and compliance. This is both a hands-on and strategic quality assurance role that requires a team player with a highly motivated attitude that will promote and cultivate cross-functional area support within the company to achieve and maintain the required levels of standards of quality and compliance, appropriate for the Mirati company GxP paradigm in balance with Mirati external GMP vendors.
- Collaborates with Analytical Development to manage, review, and approve product specifications and related analytical documentation for all Mirati's clinical products
- Ensures QA GMP SOPs are compliant and reflective of Mirati's current processes with focus on specifications, stability, reference standards, expiry assignment, and analytical method qualification program
- Collaborates with Stability team to assess temperature excursions
- Collaborates with Stability team to review and approve stability protocols, stability reports, and product retest and expiration extensions
- Collaborates with Analytical Development to review and approve analytical methods, method qualification/ validation protocols, reports, and technical transfers
- Contribute to project teams with external vendors as Mirati's primary Quality analytical contact
- Contributes to Quality Agreements for external vendors, as required
- Ensures Clinical Trial Materials (CTMs) are properly tested including review of COAs and associated release data
- Provides Quality oversight of release and stability-related OOS/OOT and related investigations
- Assists in supporting inspection readiness program and participates during inspections and audits as needed
- Supports the R&D and Quality review of CMC Sections of regulatory submissions for (e.g., NDAs, MAAs, etc.) as needed
- Partners with GMP analytical service vendors during regulatory inspections as required
- Hire, direct, develop and manage a high-performing team
What is Required
- A minimum of a Bachelor's degree in Biology, Chemistry, or related scientific field is preferred
- At least 8 to 10+ years related experience, in pharmaceutical or biotech industries, with a minimum of 6 years in GxP-related Quality environment
- Proven track record of establishing, developing, and managing the quality function and implementing phase appropriate GMP quality and compliance functions in Phase 1-3 development programs in balance with external GMP vendors
- In-depth knowledge of the applicable GMP regulations, FDA Good Clinical Practices, ICH Guidelines, FDA Regulations and Guidance
- Experience working with CMOs and experience with vendor selection and management
- Experience in dealing with regulatory authorities such as the FDA and other international regulatory authorities
- Analytical lab experience
- Small molecule IND through NDA experience
- Exceptional written and verbal communication skills
- Must possess the ability to effectively manage multiple projects
- Proven problem-solving skills
- Ability to adapt rapidly and change focus based on real time results and corporate priorities
- Commercialization experience is a plus
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.