Executive Director/Vice President, Analytical Development and Quality Control
Department: Tech Ops Executive and Administration
Employment Type: Full Time
Reference Number: 1857063
Job Description Summary
The Executive Director/Vice President, Analytical Development and Quality Control (AD&QC) will be responsible for the analytical development, method transfers, quality control, and stability program for Mirati's clinical and commercial products, critical raw materials, intermediates, drug substance and finished drug products. This position reports to our SVP of Technical Operations.
As a member of Mirati's leadership team, this role is an opportunity to bring seasoned experience and skills to build a world-class Analytical Development and QC organization. This is a strategic role that supports clinical and commercial supply and spans US and OUS territories. In close collaboration with the SVP, Technical Operations you will also serve as the lead AD&QC point of contact to all external stakeholders including collaboration partners and contract service providers and to key internal stakeholders from Development, Commercial, Quality, Finance/Accounting and Legal.
This individual will be responsible for leading Mirati's product control strategies. You will develop and execute the company's AD&QC strategy in support of the corporate development strategy and the company's deep and growing development pipeline.
This is a unique opportunity to help guide the organization through our evolution as a U.S.-based research and development organization to a global commercial-stage biotech with potential for multiple products launching beyond 2022.
- Build a world-class organization and operating environment and provide strategic AD&QC leadership and direction aligned with the Technical Operations vision, mission and goals.
- Accountable for the success of AD&QC operations to deliver on the aligned priorities of the organization.
- Responsible for the implementation and performance of integrated quality control systems, departmental policies, procedures, processes
- Lead and oversee the design and execution of phase-appropriate analytical strategies including analytical method development, justification of specifications, reference standard characterization, product characterization. and establishment of test methods to enable product QC and batch release, characterization, formulation development, comparability assessments and stability programs for small molecule drug products from the development stage to commercialization.
- Actively communicates product quality risks and trends within and outside the company.
- Develop strong functional partnerships and phase appropriate strategies with other corporate functions and execute on aligned strategies to support clinical development and commercialization plans.
- Implement an internal and external testing infrastructure to partner with other technical operations teams in the delivery and interpretation of analytical data.
- Provides oversight for contract analytical services at CRO/CDMO partners
- Provides technical support to regulatory fillings including writing and reviewing submissions, responses to questions and participation in regulatory meetings.
- Leads or manages the work of others by creating a positive environment and providing guidance to subordinates or teams based on organizational goals and policies. Develops team members to their full potential. Establishes clear expectations, sets priorities, focuses resources, and delegates effectively. Closely monitors progress and proactively addresses issues and obstacles. Flexible and responsive to change; creative problem-solving skills. Highly decisive and action-oriented. When needed, strong individual contributor, with a hands-on style.
- Continually assess the needs of the organization and build world class Supply Chain Organization to meet the Company's growing business needs.
- Responsible for providing input to annual budgets for the AD&QC function.
- Assures AD&QC operations are in compliance with regulatory standards and corporate policies
- May fill additional leadership assignments within Technical Operations as assigned.
What is Required
- Doctoral (Ph.D.) degree in relevant Science with 15+ years of industrial AD and QC experience, or MS, BS with equivalent experience.
- Demonstrated leadership experience in building highly collaborative and performing teams and developing and leading senior technical leaders
- Proven track record leading global AD&QC organizations through development and commercialization phases.
- Strong verbal and written communication skills with ability to communicate effectively at all levels and present complex and/or new ideas both internally and with external stakeholders
- Ability to excel in a fast-paced environment while managing multiple priorities, as well as a proven track record of working effectively in diverse teams involving multi-functional disciplines.
- Extensive analytical method development, troubleshooting, and validation experience. In depth experience with the development, tech transfer and validation of analytical methods.
- Strong knowledge of GLP and cGMP, worldwide regulatory requirements, current industry Practices and product development and manufacturing.
- Maintains a solid understanding of current industry trends and regulatory expectations associated with analytical science areas, including but not limited to stability studies, microbial control, comparability assessments, method validation and current and emerging analytical techniques.
- Embraces the use of data including by applying the latest means of data management and analysis including statistical process control and quality trending.
- 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.