Senior Scientist, Product Development
Department: Technical Operations / CMC
Employment Type: Full Time
Reference Number: 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.
- 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 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.