Associate Director, Packaging and Labeling
Department: Technical Operations / Supply Chain
Employment Type: Full Time
Reference Number: 1835689
Job Description Summary
We are looking for an experienced Associate Director of External Manufacturing to lead all Packaging and Labeling Finished Drug Product (FDP) engineering and outsourced manufacturing activities across Mirati's global supply chain network to support our rapidly expanding clinical pipeline and launch of multiple commercial products. This individual will report to the Senior Director of External Manufacturing. He or she will be responsible for managing multiple Contract Manufacturing Organization (CMO) sites/relationships and will be the primary point of accountability for ensuring successful, on-time production and delivery of clinical and commercial Finished Drug Product from the site.
- Responsible for ongoing management of Mirati's network of Packaging and Labeling CMOs.
- Collaborate with internal groups and CMOs to ensure successful on-time packaging introduction, which includes package design, testing, qualification/verification, overseeing packaging line qualification, shipping validations and ensuring compliance with specifications and regulatory guidelines.
- Deliver innovative, best in class packaging solutions to meet patient and business needs.
- Develop and qualify global primary and secondary packaging solutions for products through the packaging lifecycle, understanding customer needs and leveraging the organization.
- Prepare and execute package development plans, conduct experiments on-site, and supervise experiments performed at contract sites.
- Author technical reports and regulatory filing sections related to container closure system and manufacturing.
- Drive implementation of Mirati's CMO Lifecycle Management Program across our network of Packaging and Labeling CMOs. Support identification, selection, on-boarding, start-up and ongoing management of CMO's.
- Lead CMO management activities, including business and manufacturing support, issue resolution, and performance management. Lead weekly cross-functional site leadership team meetings with CMO to ensure all start-up and production activities are conducted successfully on-time.
- Understand CMO partner internal structure and processes and work with team to ensure successful production, issue resolution and communication takes place to meet Mirati's production requirements.
- Lead site issue management and resolution during routine production and escalate issues, when appropriate. Drive risk management activities, including the identification of risks and creation of mitigation plans. Support product transfer activities to the CMO.
- Work in conjunction with CMO counterpart to lead quarterly business reviews with senior leadership from Mirati and CMO. This includes tracking all relevant performance metrics, scheduling leadership team visits to the site and co-presenting to the site steering committee on successes, challenges, plans, risk mitigation and continuous improvement activities at the site.
- Establish and maintain effective relationships with key CMO stakeholders to ensure successful manufacture and issue resolution across the external manufacturing network. Foster collaborative relationships with internal stakeholders (e.g. Clinical Operations, Development, Regulatory, Quality, Operations, Finance, etc.) to understand organizational needs.
- Create and manage contracts, requests for pricing, supply agreements, etc. Ensure activities are executed in alignment with established Supply and Quality Agreements. Work with stakeholders and suppliers to help drive business issues to resolution. Understand contractual / financial implications of issues and solutions and ensure appropriate outcomes are implemented. Manage and communicate forecasts to the sites. Support capacity planning activities.
- Manage CMO Performance. Measure and report on the overall performance of each CMO. Identify and drive performance improvements (COGS, cycle time, quality, etc.) to ensure efficient, reliable supply of all clinical and commercial products.
- Work collaboratively with Project Management to ensure projects from conception to implementation and close-out, as directed by management.
- Support drug product manufacturing, as needed.
What is Required:
- BA or BS degree in Engineering, Chemistry or another relevant field.
- 10+ combined years of experience in cGMP Manufacturing, Contract Manufacturing or Quality.
- Direct experience in Packaging and Labeling manufacturing supporting both clinical and commercial tablet and capsule drug product.
- Direct experience in drug product manufacturing supporting both clinical and commercial needs.
- Experience working with International Contract Manufacturing Organizations.
- Excellent written and oral communication and presentation skills.
- Strong problem solving, decision making, planning, analytical and project management skills.
- Ability to travel approximately 40% - both domestically and internationally
- Position will be remote.
- Master's Degree
- Lean Six Sigma/Operational Excellence 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.