Senior Manager, Labeling - Supply Chain -
Department: Technical Operations / Supply Chain
Employment Type: Full Time
Reference Number: 1796915
Job Description Summary
Mirati Therapeutics is seeking to hire a Senior Manager, Labeling - Supply Chain, who will own and facilitate the process for clinical / commercial artwork development, labeling, and documentation for all Mirati clinical programs and pre-commercial to commercial products. This individual will lead and manage all clinical packaging & labeling initiatives through the review and approval process as well as implementation with external labeling and packaging CMO's. The incumbent will interact cross-functionally with members of Regulatory Affairs, Commercial, Medical Affairs, Quality and others to develop, review, implement and provide systems support of GMP labeling and will integrate complex programs that may require multinational interactions and cross functional partnership.
- Implement best in class labeling development process that meets the needs of current and future clinical and commercial pipeline.
- Establish resource plan for labeling development functional expansion by evaluating upcoming clinical landscape.
- Manage and drive performance through well-defined KPIs
- Manage technical requirements of labeling to ensure it meets the technical standards/specifications for contract manufacturer organizations (CMO)'s capabilities
- Coordinate and manage the change control process for all GMP labeling development and label maintenance for all Mirati clinical and commercial programs.
- Manage internal documentation requirements including change controls specifications, item code creations, pertinent SOPs and artwork libraries.
- Coordinate review, obtain internal approvals and ensure labeling follows Quality system requirements, GMP and applicable domestic, international regulatory requirements and anti-counterfeiting provisions.
- Along with Regulatory Affairs, coordinate artwork translations.
- Oversee generation of final proof copy/transparency proof and creation of print-ready artwork files Serve as the primary information base for all issues related to product labeling/printed components and clinical packaging and labeling.
- Ensure labeling artwork generated is in conformance with source text.
- Support Regulatory Affairs in packaging responses to Health Authorities.
- Tracking of all versions, specifications and coding for each labeling component for all GMP labeling.
- Follow latest standards for UPC/GTIN number assignment.
- Ensure US DSCSA and EU FMD implementation and compliance.
- Support pre-commercial label and package design process
- Support Serialization management.
- Participate in the development and maintenance of work practices, templates, and associated documents relating to the labeling function
- Employ measures for counterfeit protection to implement overt and covert anti-counterfeiting technologies for commercial products
Experience and Qualifications:
- BS/BA degree is required (packaging engineering, supply chain, or similar); Masters is preferred. At least 5 years of related Industry experience is required.
- Experience in cGMP packaging operations is required with knowledge of clinical trials operations is necessary.
- Candidates should have a strong understanding of US and EU regulations on labeling and packaging implementation
- Keen attention to detail and accuracy is important.
- Excellent verbal and written communication skills in English is necessary.
Experience in packaging labeling development is necessary
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.