Pharmaceutical Process Engineer
Department: Technical Operations / CMC
Employment Type: Full Time
Reference Number: 1621126
Job Description Summary
The Pharmaceutical Scientist/Process Engineer reports to the Director of Process Development within the Technical Operations group and will support process development, process scale-up, process validation, tech-transfer and commercial operations of Mirati assets at various CMOs.
- Independently designs experiments and carries out scientific work, including authoring or review of Gdocumentation, such as experimental reports, batch records, development and technology reports.
- Responsible for assisting with support of GMP engineering runs, process validation and commercial manufacture at external CMOs.
- Performs process monitoring and data tracking and trending of key attributes to ensure process remains in-control.
- Lead investigations/OOS related to processing to identify root cause and corrective actions.
- Maintain up to date scientific knowledge through regular literature review and participation in conferences
What is Required:
- S. degree in engineering, science, or closely related discipline is desired with 8+ years of significant experience. Familiarity with Six Sigma and/or statistical tools a plus.
- Solid understanding of unit operations including dry granulation, blending, tableting, coating and encapsulation
- Proven strong analytical skills
- Working knowledge of cGMP and current industry best practices
- Strong interpersonal and communication skills including attention to detail
- Builds solid cross functional relationships with other areas including Analytical, Regulatory and Quality
- 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.
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.