1728874

Job Description Summary

The Sr. Scientist, Product Development will be responsible for late stage development of small molecule solid oral drug products for clinical studies and commercialization. He/She will provide technical support towards formulation and process development, scale-up, and tech-transfer activities conducted in-house and at external contract development & manufacturing organizations (CDMO’s). He/she will work effectively with cross-functional groups, including analytical development, process chemistry, clinical, quality and regulatory, to ensure that drug products are developed and manufactured in compliance with all applicable regulations and corporate procedures (GLP, GMP, ICH). He/she will support activities related to author / review relevant sections of the CMC regulatory dossiers.

Your Responsibilities:

  • Design of experiments and execute them by employing quality by design (QbD) principles to develop robust formulations and manufacturing processes for different phases of drug product development.
  • Perform pilot and commercial process characterization and scale-up of various pharmaceutical unit operations during product development by using first principles, process modeling, proper experiments, and statistical analysis.
  • Screen, identify, and manage drug product manufacturing sites/technologies (CDMOs) of oral solid dosage drug products.
  • Optimize manufacturing processes of drug products based on current regulatory guidelines related to pharmaceutical development.
  • Review and approve batch records, protocols and technical reports.
  • Provide technical assistance and act as Person in Plant (PiP) during Technology Transfer to CDMO partner sites for manufacturing of different phases of clinical studies, registration stability lots, validation batches, and commercial lots.
  • Author technical documents for formulation and process development and contribute to preparation of CMC sections for regulatory filings (IND, NDA, MAA).
  • Work closely with other internal cross functional groups such as Analytical, Quality, Regulatory, and Commercial teams to ensure all drug product requirements are met.
  • Perform FMEA and risk assessment from early stage process development to late stage commercialization.
  • Perform continuous process verification (CPV) of critical process parameters (CPPs) and critical quality attributes (CQAs) of marketed and under development drug products. Perform statistical analysis and conduct regular product specific data trending.

What is Required:

  • Doctorate (Ph.D.) or Masters (M.Sc.) degree Master in Chemical Engineering, Pharmaceutics, Pharmaceutical Sciences, or other Life Sciences related fields, with 4+ years of relevant pharmaceutical industry experience, or B.S. with 8+ years of relevant experience.
  • Fundamental understanding of first principles underlying drug product manufacturing processes.
  • Technical expertise and hands-on experiences in solid oral dose formulations and related manufacturing unit operations such as: Dry/Wet Granulation, Milling, Blending, Compression, and Film Coating.
  • Experience in solid dosage pharmaceutical process development, technical transfer, scale-up and process validation at CDMOs.
  • Experience in using statistical analysis software and risk assessment tools to implement the Quality by Design (QbD) elements during product life cycle.
  • Enriched knowledge of cGMP requirement for drug product development and manufacturing.
  • Experience in project management and ability to work in a cross-functional working groups.
  • Excellent interpersonal skills with the ability to interact professionally and effectively with peers, management, and leadership both within and outside the company.
  • Excellent verbal and written communication skills with strong technical report writing.
  • 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 KRAS G12C 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 KRAS G12D 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.

For more information about Mirati Therapeutics, visit us at Mirati.com or follow us on LinkedIn.

Why Join?

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.

1723388

Your Responsibilities

  • Development, pre-validation and troubleshooting of analytical test methods for drug substances (small molecules), raw materials, process intermediates, and drug products (capsules, tablets)
  • Closely collaborate with Chemical Development and Product Development during development
  • Perform excipient compatibility and stability studies to aid with formulation selection
  • Independently design and conduct analytical experiments
  • Implement new experimental protocols/techniques
  • Interpret results and draw conclusions from experiments; design and pursue relevant experiments
  • Evaluate data and summarize in associated reports and documentation
  • Understand relevant scientific literature and apply theoretical framework to solving problems within scientific discipline in a timely manner
  • Perform routine and complex tasks competently and independently and generate reliable and consistent results.
  • Interact with cross-functional teams with internal and external team members from various functional departments including Chemical Development, Product Development, Quality Assurance, and Regulatory
  • Maintain analytical instrument in the Analytical Development laboratory, coordinate with vendors for the period qualification of equipment

What is Required

  • Bachelor’s Degree or equivalent education with at least 5 years of pharmaceutical experience, or Master’s Degree or equivalent education with at least 3 years of pharmaceutical experience
  • Theoretical and practical knowledge to carry out the job functions
  • Extensive experience with chromatographic techniques (HPLC, GC) and equipment troubleshooting is a must
  • Experience with other common analytical techniques is preferred (LC-MS, FTIR, UV, Karl Fischer, dissolution, particle size, etc)
  • Experience with data management and statistical tools is preferred
  • Excellent documentation practices and report-writing skills
  • Solid communication skills

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 KRAS G12C 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 KRAS G12D 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.

For more information about Mirati Therapeutics, visit us at Mirati.com or follow us on LinkedIn.

Why Join?

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.

1750363

Job Description Summary

This position is responsible for the development and maintenance of investigational material supply plans and strategies for early and late stage small and large molecule development compounds throughout the life of a clinical study. As the clinical supply chain’s primary input to cross functional teams (CMC team, project team, study team, etc.), the role liaises with the cross functions to proactively assemble key program/protocol attributes necessary to generate approvable clinical supply strategies and plans. With an advanced understanding of clinical protocol design and the risks associated with clinical supply chain activities, the CSPM is a key driver of the decisions that impact a clinical study’s supply strategy by being a vocal member on teams while representing the clinical supply chain. The role will also work closely with vendors and internal support resources to ensure the on-time execution of activities in order to meet supply milestones.

Your Responsibilities:

  • Responsible for review of clinical protocols and the development of supply chain strategies that ensure alignment with the clinical study plan, milestones, and the clinical development plan.
  • Through a knowledge of clinical study design, the CSPM contributes to and influences protocol content and supply strategy to minimize drug supply and patient compliance risks.
  • Engages cross functional peers to drive key decisions required to develop supply strategies and study objectives.
  • Directs the planning and execution of clinical supply packaging, labeling, and logistics events with vendors to ensure timely delivery to support clinical studies.
  • Working with vendors and internal resources, develops the strategy for comparators, labels, packaging, distribution and returns strategies.
  • Provides input to the development of investigational product related content in study documents including investigator meeting documents, protocols, and pharmacy manuals
  • Responsible to raise and communicate supply chain risks that may impact initial and on-going supply continuity, while presenting risk mitigation strategies to enable continuity.
  • Contributes to the development of IRT system user requirements (URS) and user acceptance testing while ensuring the system manages drug supply effectively.
  • Responsible for monitoring/facilitating drug supply events within IRT from study start-up through study closure
  • Develops demand/supply forecast and communicates plans to key stakeholders (CMC, Manufacturing, etc.).
  • Responsible to develop clinical supply budget and monitoring expenditures against the supply budget.

What is Required:

Degrees:

  • BS/BA degree in related discipline and five to eight plus years of clinical supply project management experience preferred.
  • Professional Project Management certification is also desirable

Experience:

  • Proficient knowledge of protocol interpretation, IRT URS development and UAT.
  • Understanding of clinical supply interdependencies within the drug development process and clinical study execution.
  • Demonstrated experience developing working with clinical supply vendors.
  • Knowledge of temperature-controlled distribution, import/export and logistics
  • Broad knowledge of and experience with cGMP, GDP and GCP standards and guidance documents such as Annex 13.
  • Broad knowledge of CMC, manufacturing, Quality Assurance, Clinical operational processes
  • Demonstrated experience in global clinical supply forecasting and planning, packaging and labeling operations, IRT and clinical trial design

Skills:

  • Proficiency with standard Microsoft applications (MS Word, MS Excel, MS PowerPoint, MS Project, MS Visio).
  • Demonstrated ability in communicating, influencing and driving decisions while a member of cross functional teams supporting clinical studies.
  • Ability to effectively work in complex, dynamic and fast paced drug development environment.

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 KRAS G12C 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 KRAS G12D 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.

For more information about Mirati Therapeutics, visit us at Mirati.com or follow us on LinkedIn.

Why Join?

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.

1646862

Our mission is to discover, design, and deliver breakthrough therapies to transform the lives of cancer patients and their loved ones. We have built a culture fueled by accountability, urgency, collaboration and open-mindedness, and have established ourselves as an innovator within our industry. As we grow, we are looking to build diverse teams, with skilled individuals that are passionate about their work.

Your Responsibilities:

  • Provide technical leadership to define, develop, characterize, optimize, and transfer manufacturing processes to contract manufacturing organizations.
  • Solve challenging, interdisciplinary technical problems at the interface of chemistry and material science.
  • Trouble-shoot and provide sustainable solutions for root cause processing problems
  • Design and execute controlled experiments to optimize manufacturing processes, quality, cost, and throughput. Drive implementation of solutions into manufacturing to meet company and project goals.
  • Coordinate with CMO’s to ensure the process, the plant, the automation & process operators are appropriately aligned to run processes per Process Safety & Product Quality attributes.
  • Define technical and operational process requirements. Translate technical requirements to define and document manufacturing specifications, procedures, and controls.
  • Manage the equipment & unit operation process knowledge, information and data requirements associated with production.
  • Represent Chemical Process R&D on development teams and other cross-functional teams.

What is Required:

  • D. or M.S. in Engineering or related field with minimum of 8 years relevant industry experience
  • Proven track record of success in pharmaceutical manufacturing operations.
  • Demonstrated experience in characterization and testing of complex systems, including design of experiments and root cause analysis
  • Strong interdepartmental communication, influence, and documentation skills are required.
  • Demonstrated ability to accomplish goals while working across departments is required.

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 KRAS G12C 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 KRAS G12D 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.

For more information about Mirati Therapeutics, visit us at Mirati.com or follow us on LinkedIn.

Why Join?

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.

1711922

Job Description Summary

The Associate Director of Regulatory Chemistry, Manufacturing and Controls (CMC) will report directly to the Vice President of Regulatory CMC. The individual will be responsible for working with the CMC teams to guide the CMC global regulatory strategy of Mirati’s small molecule programs leading to successful preparation and approval of Investigational New Drug applications (INDs), Clinical Trial Applications (CTAs), New Drug Application (NDA), and Marketing Authorization Application (MAA) submissions. The ideal candidate will have a strong CMC technical background, experience with preparing CMC regulatory submissions, and responding to Health Authority questions. In addition, excellent verbal and written communications skills are required.

Your Responsibilities:

  • Participate as the Regulatory CMC Lead on CMC Teams
  • Lead the preparation of regulatory dossiers (e.g. IND, IMPD, NDA, and MAA) for submission to global Health Authorities in compliance with departmental and regulatory standards
  • Research and provide analysis of current US and international regulations and guidance
  • Develop and execute global CMC regulatory strategies for analytical, chemical, and product development for small molecule oncology compounds
  • Actively participate on Global Regulatory Team(s) to develop global submission plans that comply with local regulatory requirements
  • Develop and get buy-in on regulatory CMC strategy for Health Authority responses as needed
  • Review and guide content of CMC information in nonclinical and clinical documents including clinical protocols and investigator brochures
  • Communicates critical issues to Management

What is Required:

  • A minimum of a Bachelor of Science in chemistry or pharmaceutical science with a minimum of 8 years of experience inclusive of post graduate education and/or pharmaceutical or health care industry experience or equivalent is required
  • An MS, Ph.D., or Pharm. D. degree preferred
  • Knowledge of EU and FDA regulations is required
  • Experience directly writing submission documents that support clinical trials. Experience writing marketing applications is highly desirable
  • Experience developing regulatory strategies and an understanding of product development, seen as an expert on product development and how it is applied in global regulatory strategy is required
  • Strong attention to detail with high-level verbal and written communication skills is required
  • Ability to work as part of and lead multiple teams, and to present and defend CMC management-approved regulatory strategy and opinion to project teams is required
  • Exhibits leadership skill and ability, typically leads lower levels and/or indirect teams
  • Excellent problem-solving, analytical thinking skills is required

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 KRAS G12C 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 KRAS G12D 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.

For more information about Mirati Therapeutics, visit us at Mirati.com or follow us on LinkedIn.

Why Join?

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.

1673516

Job Description Summary

The Sr Principal Scientist of Chemical Development will be responsible for the design, development and implementation of robust synthetic processes to support Mirati’s small molecule programs with the goal of delivering preclinical and clinical drug substance batches meeting program needs. Individual will be accountable for implementing phase appropriate strategies to develop synthetic processes that comply with regulatory requirements and manufacturing API to support clinical trials, registrational and commercial batches

Your Responsibilities:

  • Lead and manage CRO/CMO activities, define and develop stage appropriate sourcing strategy to meet objectives of Mirati’s small molecule development programs.
  • Direct chemical process development activities for one or two primary programs and contribute to all other development programs as needed.
  • Provide manufacturing oversight for the production of drug substances.
  • CMC Regulatory writings to support regulatory submissions.
  • Responsible for phase appropriate synthetic route design, practical implementation of synthetic processes and controls for regulatory starting materials, intermediates and drug substances.
  • Lead fate and tolerance studies, genotoxic impurity evaluation and establish the framework of for the control strategy of the drug substance from early development with a long-term vision of the commercial process.
  • Lead/support technical transfer of starting material, intermediate or API processes between sites.
  • Work closely with cross functional teams to ensure seamless transitions between drug substance and drug product programs and suppliers.
  • Ability to coordinate with internal and external quality control, quality assurance, and regulatory personnel to resolve technical issues or deviations during production.
  • Participate in an interactive, team oriented collaborations with the discovery functions and the tech operation/CMC teams.
  • Critically review proposals from CROs or CDMOs; perform appropriate due diligence as needed to ensure CROs and CDMOs can support the requirements of individual chemical development programs effectively.
  • Implementation of risk based approach to development, QbD and DoE principles at appropriate development stages
  • Support PAR studies and pre-validation and validation activities for drug substance.
  • Author, review, and adjudicate relevant CMC sections for US and ex-US regulatory filings as needed.
  • Build appropriate risk management strategies for chemical development and manufacturing.
  • Up to 25% travel will be needed for scientific project management and monitoring of critical project activities

What is Required:

  • PhD or MS with >10-15 years of experience in organic chemistry, chemical engineering, and related discipline with relevant drug substance development experience in pharmaceutical and biopharmaceutical industries.
  • Knowledge of current Good Manufacturing Practices (cGMP).
  • Demonstrated knowledge of drug development, CRO/CDMO management, manufacturing, supply chain management and regulatory CMC.
  • Proven ability to develop and implement strategic plans.
  • Ability to effectively organize and prioritize tasks to achieve established objectives and deadlines.
  • Demonstrated competencies in a core CMC discipline such as drug substance process development, drug substance manufacturing.
  • Proven problem solving skills and excellent track record of accomplishments.
  • Must possess the ability to effectively manage multiple projects, organize and lead R&D activities.
  • Ability to adapt rapidly and change focus based on real time results and findings.
  • Exceptional written and verbal communication skills.

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 KRAS G12C 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 KRAS G12D 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.

For more information about Mirati Therapeutics, visit us at Mirati.com or follow us on LinkedIn.

Why Join?

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.

1714120

Job Description Summary

The position will oversee stability activities within the Analytical Development function. He/she will be responsible for the design, implementation, review, and tracking of stability studies as well as stability data trending for development projects, from pre-clinical lead candidate selection through clinical development, registration filings and up to commercialization. He/she will provide guidance on the design of stability studies to support clinical studies and regulatory submissions. He/she will be responsible for authoring the stability sections of regulatory filings. He/she will provide guidance and support to internal groups such as regulatory, quality and manufacturing as well as to outside groups such as contract manufacturing organizations to ensure that stability studies are conducted in compliance with all applicable regulations and corporate policies and procedures (GLP and GMP).

Your Responsibilities:

  • Develop and recommend stability strategy and study design for drug substance and drug product
  • Oversee stability study design, execution, monitoring, reporting, data management (collection and archiving), and data trending and analysis for studies performed at contract service providers
  • Provide leadership for stability deviation events, failure investigations, and temperature excursion reports
  • Oversee stability testing for development, clinical and commercial materials
  • Provide retest period/shelf life recommendations based on available stability data and statistical analysis in accordance with ICH guidelines
  • Lead implementation of corrective actions and quality system improvements related to the stability program
  • Participate in selection and audits of contract service providers used for stability studies
  • Authors stability sections for regulatory filings
  • Maintain up-to-date scientific knowledge through regular literature review and participation in conferences. Leverage external data and publications and relevant industry benchmarking information to drive experimental design, data analysis and functional/cross-functional strategy development
  • Represent stability function in CMC teams and interdepartmental meetings
  • Identify, manage and coordinate outsourcing activities when appropriate
  • Serve as primary liaison with outside stability vendors on projects
  • Ensure studies are conducted in compliance with GLP and GMP regulations, as applicable

Assist with Product Quality Trending of release data to support process capability analysis and specification justification

What is Required:

  • Masters (M.S.) degree in Analytical Chemistry or related discipline plus 5-8+ years of relevant industry experience, or BS and 8-10+ years of experience
  • Practical experience in scientific discipline and in managing stability studies (2+ years)
  • Ability to independently design, conduct and interpret laboratory studies
  • Ability to evaluate analytical test results (HPLC, GC, dissolution, compendial methods, etc.)
  • Experience preparing and maintaining regulatory filings (IND, NDA, MAA)
  • Successful history building and managing analytical stability functions
  • Strong written and verbal communication skills
  • Ability to effectively organize and prioritize tasks to achieve established deadlines
  • Ability to multi-task and good adapt rapidly to changing business requirements in a dynamic corporate environment
  • Proven problem-solving skills are a must
  • 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 KRAS G12C 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 KRAS G12D 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.

For more information about Mirati Therapeutics, visit us at Mirati.com or follow us on LinkedIn.

Why Join?

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

1704241

Job Description Summary

This position will be responsible for the sourcing, characterization, inventory, maintenance, and shipment of reference standards and markers in support of activities for new drug substances and new drug products. He/she will endure that reference materials are synthesized and characterized to support analytical activities (testing, method validation, etc) in compliance with applicable guidelines and procedures for clinical, registrational, and commercial batches.

Your Responsibilities:

  • Maintain the reference standard inventory and ensure that materials are retested at regular intervals.
  • Review reference standard documentation, including reference standard COAs and characterization reports.
  • Work with Chemical Development to coordinate the sourcing of new reference standard materials within project timelines.
  • Establish workflows and procedures to standardize reference standard activities.
  • Develop plan for introduction of new reference standard lots.
  • Coordinate shipment of reference standards between sites.
  • Manage analytical activities at CROs/CMOs related to characterization testing and retest of reference standards. Review analytical raw data packages. Ensure studies are conducted in compliance with GLP and cGMP regulations, as applicable.
  • Provide technical support in resolving technical issues, reviewing deviation events and failure investigations at contractor sites in coordination with internal and external. quality control, quality assurance, and regulatory groups, as appropriate. Provide technical input for OOS and OOT investigations.
  • Provide support in authoring or review of analytical sections of chemistry, manufacturing and control (CMC) sections of regulatory submissions, as needed.
  • Maintain up-to-date scientific knowledge through regular literature review and participation in conferences. Leverage external data and publications and relevant industry benchmarking information to drive experimental design, data analysis and functional/cross-functional strategy development.
  • Represent analytical function in CMC teams and interdepartmental meetings.

What is Required:

  • Doctoral (Ph.D.) or Masters (M.S.) degree in Analytical Chemistry or related discipline plus 5+ years of relevant industry experience, or BS +8 or more years’ experience
  • Experience with analytical development of small molecules and solid oral dosage forms in various stages of development (preclinical to Phase 3)
  • Experience with reference standard qualification and the identification of impurities and degradation products.
  • Extensive hands-on experience of CMO management for analytical projects.
  • Working knowledge of GLP and cGMP, worldwide regulatory requirements, and current industry practices
  • Outstanding written and verbal communication skills
  • Ability to effectively organize and prioritize tasks to achieve established deadlines
  • Ability to multi-task and good adapt rapidly to changing business requirements in a dynamic corporate environment
  • Proven problem-solving skills are a must
  • 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 KRAS G12C 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 KRAS G12D 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.

For more information about Mirati Therapeutics, visit us at Mirati.com or follow us on LinkedIn.

Why Join?

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.

1708173

Job Description Summary

The position will oversee stability within the Technical Operations CMC department, and will report to the Head of Analytical Development. He/she will be responsible for the overall stability strategy as well as stability monitoring and data trending for development projects from pre-clinical through clinical development, registration filings and up to commercialization. He/she will provide guidance on the design of stability studies to support clinical studies and regulatory submissions. He/she will provide guidance and support to internal groups such as regulatory, quality and manufacturing as well as to outside groups such as contract manufacturing organizations to ensure that stability studies are conducted in compliance with all applicable regulations and corporate policies and procedures (GLP and GMP).

Your Responsibilities:

  • Develop and recommend stability strategy and study design for drug substance and drug product
  • Oversee stability testing for development, clinical and commercial materials
  • Establish stability systems with the implementation of new SOPs and workflows, as well as stability tools (stability database, trending software, etc), to streamline stability operations.
  • Oversee stability study design, execution, monitoring, reporting, data management (collection and archiving), and data trending and analysis for studies performed at contract service providers
  • Provide leadership for stability deviation events, failure investigations, and temperature excursion reports
  • Provide retest period/shelf life recommendations based on available stability data and statistical analysis in accordance with ICH guidelines
  • Lead implementation of corrective actions and quality system improvements related to the stability program
  • Analyze and present stability data at quarterly and ad hoc meetings. Author stability sections of regulatory filings.
  • Participate in selection and audits of contract service providers used for stability studies
  • Maintain up-to-date scientific knowledge through regular literature review and participation in conferences. Leverage external data and publications and relevant industry benchmarking information to drive experimental design, data analysis and functional/cross-functional strategy development
  • Represent stability function in CMC teams and interdepartmental meetings
  • Identify, manage and coordinate outsourcing activities when appropriate
  • Ensure studies are conducted in compliance with GLP and GMP regulations, as applicable
  • Assist with Product Quality Trending of release data to support process capability analysis and specification justification

What is Required:

  • Doctoral (Ph.D.) or Masters (M.S.) degree in Analytical Chemistry or related discipline plus 15 years of relevant industry experience, or BS +18 years of experience
  • Successful history building and managing stability functions
  • Hands-on experience managing stability studies at multiple sites (10+ years)
  • Ability to independently design, conduct and interpret laboratory studies
  • Experience writing stability sections of regulatory filings (IND, NDA, MAA)
  • Strong written and verbal communication skills
  • Ability to effectively organize and prioritize tasks to achieve established deadlines
  • Ability to multi-task and good adapt rapidly to changing business requirements in a dynamic corporate environment
  • Proven problem-solving skills are a must
  • 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 KRAS G12C 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 KRAS G12D 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.

For more information about Mirati Therapeutics, visit us at Mirati.com or follow us on LinkedIn.

Why Join?

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.

1693382

Job Description Summary

The Scientific Director, Pharmaceutical Preformulation, will be responsible for leading technical activities related to preformulation and developability assessments of new molecular entities (NCE’s), and selecting formulation approaches for early-stage clinical trials (FIH, Phase1-2). The scope includes evaluation of novel or established drug-delivery, formulation, or manufacturing process technologies for overcoming product developability challenges (e.g. solubility, permeability, stability, ADME). He/she will serve as a subject matter expert in areas related to preformulation and drug delivery platforms for small-molecule therapeutics.

Your Responsibilities:

  • Lead preformulation activities internally and/or at external contract research organizations. Scope includes oral solid dosage forms as well as parenterals.
  • Develop standard approaches for preformulation screening of NCE’s, and design decision-trees to guide formulation selection decisions. Design effective strategies for developing drug product via conventional methods or drug delivery / process technology approaches.
  • Design and implement efficient studies & DOE’s to assess product developability risk and demonstrate formulation viability (e.g. screening & optimization of pH, excipient levels, stabilizers).
  • Engage with discovery research & pre-clinical teams for biopharmaceutics assessment of NCE’s, pharmaceutical candidate optimization activities, and product developability evaluations. Support preclinical team, as needed, in the development of optimal formulations for toxicology studies.
  • Engage with API process chemistry and material science teams to ensure drug substance with appropriate physico-chemical properties is advanced for product development. Support material characterization efforts – polymorphic form, mechanical attributes, particle size assessment, physicochemical stability, etc.
  • Work cross-functionally with discovery research, clinical, process chemistry, analytical, regulatory, and related teams to achieve program objectives. Author / review study protocols, technical reports, and relevant sections of regulatory documents (e.g. IND, IB, IMPD).
  • Maintain up-to-date scientific knowledge through regular literature review and participation in conferences. Leverage external publications and relevant industry benchmarking metrics to streamline organizational early-to-late stage product development workflows.

What is Required:

  • Doctorate (Ph.D.) or Masters (M.S.) degree in Pharmaceutics, Pharmaceutical Science, Physical Chemistry, or a related discipline, with 10+ years of relevant industry experience, or BS with 15+ years of relevant experience.
  • High competency in preformulation, biopharmaceutics and physicochemical characterization aspects pertinent to small-molecule drug product development.
  • Strong scientific understanding of principals related to physical chemistry and pharmaceutics – including pKa, LogP/LogD, solubility (e.g. pH-solubility profile, solubilization, cosolvents), solid-state (e.g. polymorphism, crystal habit, size, surface characteristics, mechanical properties), molecular optimizations (e.g. salt, hydrate, solvate, co-crystals), degradation pathways (e.g. hydrolysis, oxidation, temperature, light).
  • Adept in material characterization techniques including x-ray diffractometry, spectroscopy (e.g. FTIR, Raman, NMR, MS, UV/VIS etc.), particle and powder characterization, dynamic vapor sorption, mechanical and thermal analyses.
  • In-depth knowledge of proprietary and non-proprietary formulation and process technology approaches for compound enablement (e.g. solubilized formulations, spray dried systems, amorphous drug in polymeric matrices, modified release formulations, permeation enhancers, liposomes, etc.).
  • Experience working with drug discovery & pre-clinical teams to assess product developability. Hands-on experience with GastroPlus or related tools is a plus.
  • Ability to independently design and implement study plans internal or external CDMO sites. Capability to adapt and improvise based on real time results and findings.
  • Exceptional written and verbal communication skills. Ability to lead project teams.
  • Experience in authoring and review of regulatory submissions (e.g. IND, IB, IMPD), protocols and related development reports. Strong understanding of ICH, cGMP, worldwide regulatory requirements and industry best practices.
  • Ability to travel up to 20% 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 KRAS G12C 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 KRAS G12D 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.

For more information about Mirati Therapeutics, visit us at Mirati.com or follow us on LinkedIn.

Why Join?

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.

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