Senior Director, External Manufacturing
Department: Technical Operations / Supply Chain
Employment Type: Full Time
Reference Number: 1829569
Job Description Summary
We are looking for an experienced Senior Director of External Manufacturing to lead all outsourced manufacturing activities across Mirati's global supply chain network as we continue expand our clinical pipeline and prepare for launch of Mirati's first commercial product. This individual will report to the Vice president of Manufacturing and Supply Chain and will be responsible for implementation and management of the company's overall Contract Manufacturing Organization (CMO) management program including relevant processes, procedures, metrics, team structure, and governance/business reviews with key supply partners. He/she will be a proven leader with extensive outsourced manufacturing experience and will be responsible for recruiting, developing and leading a team of site managers with primary accountability for overseeing Mirati's Drug Substance (DS), Drug Product (DP) and Labeling/Packaging CMOs.
- Implement and lead Mirati's CMO Management Program. Establish the required team structure, processes, metrics, and governance necessary to ensure adequate oversight of Mirati's external manufacturing network.
- Recruit, onboard, develop and lead a team of exceptional manufacturing professionals to directly lead cross-functional teams responsible for ensuring successful planning, manufacture, release and shipment of clinical and commercial products.
- Directly engage and build relationships with CMO senior leadership to ensure ongoing successful manufacture and issue resolution across the external manufacturing network. Plan, coordinate and facilitate all senior leadership site business reviews and visits including participation from senior leadership from Mirati and our CMO partners.
- Measure and report to Mirati senior leadership on overall performance of our CMO network. Work in a collaborative fashion with internal Mirati stakeholders and our CMOs to identify and drive performance improvements (COGS, cycle time, quality, etc.) to ensure efficient, reliable supply of all clinical and commercial products.
- Identify risks (business, performance, quality, regulatory, external, etc.) to ensure supply and work with site leaders, CMOs and internal stakeholders to develop effective mitigation plans. Provide input on CMO related risks to inform Mirati's overall supply chain and corporate risk management programs.
- Work directly with heads of Strategic Planning, Long Range Planning and Strategic Sourcing to ensure that Mirati's long term global manufacturing needs are met. This includes input on existing site performance and capabilities, capacity expansion options/costs/lead times, participation in new vendor selection and start-up, and input on strategic imperatives required to improve Mirati's functional capabilities to achieve competitive advantage.
- Foster collaborative relationships with internal stakeholders (e.g. Clinical Operations, Development, Regulatory, Quality, Operations, Finance, etc.) to understand organizational needs.
- Support global regulatory filings and quality audits/inspections as required.
What is Required
- BA or BS degree in Engineering, Chemistry or another relevant field.
- 16+ combined years of experience in Manufacturing, Contract Manufacturing or Quality.
- Direct experience in small molecule Drug Substance and Drug Product manufacturing supporting both clinical and commercial products.
- International CMO management experience.
- Management experience and team development.
- Excellent written and oral communication and presentation skills.
- Strong problem solving, decision making, planning, analytical and project management skills.
- Ability to travel approximately 40%
- Position will be based in San Diego, CA
- Master's Degree
- 8+ years supervisory experience
- Operational Excellence/Lean Six Sigma background
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.