Job Opportunity

Principal Scientist, Product Development

Location: San Diego, CA, US
Department: Technical Operations / CMC
Employment Type: Full Time
Reference Number: 2538160

We are Mirati

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.

Why join us?

The Principal Scientist, Product Development will be responsible for design and development of small molecule oral solid dosage drug products for different phases of clinical studies and commercialization. He/she will serve as a subject matter expert in product development related activities for new product introductions, and product lifecycle. He/she will provide technical expertise towards formulation, 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, regulatory, and supply chain to ensure that drug products are developed and manufactured in compliance with all applicable regulations and corporate procedures (GLP, GMP, ICH).

Your Responsibilities:

  • Design and develop optimal formulations, and robust, scalable and cost-effective processes for the manufacture of drug products for clinical studies and commercialization. Design and implement efficient DOE's to support formulation and process robustness.
  • Support material characterization efforts such as solid state form, mechanical attributes, particle size assessment, and physicochemical stability. Collaborate effectively with API process chemistry group to ensure drug substance with optimal physico-chemical properties is advanced towards commercialization.
  • Support preclinical team in the production of optimal formulations and preparation procedures for toxicology and DMPK studies. Provide technical inputs for clinical dosage form bridging strategies and to manage potential scale-up and post-approval changes.
  • Lead screening, selecting, and managing drug product manufacturing sites/technologies (CDMOs) of oral solid dosage drug products.
  • Lead process scale-up and tech-transfer of various pharmaceutical unit operations using Quality by Design (QbD) elements such as FMEA, Design of Experiments (DoEs), statistical analysis, first principles, and process modeling.
  • Late stage drug product Subject Matter Expert for oral solid dosage forms, providing technical direction during drug product development at Mirati R&D lab and at CDMOs.
  • Author / review manufacturing batch records and study protocols. Author / coordinate preparation of high-quality technical reports and integrated project summaries.
  • Author/ review CMC regulatory documentation for IND, IMPD, NDA, and MAA filings, covering all phases of clinical development and commercial launch. Assist during quality events (QEs) or failure investigations and implementation of CAPAs at contractor sites.
  • Support design of primary, secondary, and tertiary packaging/labeling solutions for drug products. Support related activities for qualification and validation in collaboration with supply chain and quality functions.
  • Lead drug product post-launch assessments such as Continued Process Verification (CPV) and Continuous Process Improvement (CPI) by utilizing technological innovation and Lean Six Sigma methodologies.
  • Build strong relationships with contract manufacturing partners, contract manufacturing Quality, and drug product manufacturing process technical teams. Support evaluation of product impact from manufacturing processes, production scale, equipment, and raw material changes.
  • Maintain up-to date scientific knowledge of pharmaceutical process engineering through regular literature review and participation in conferences/industry consortium to keep Mirati at the forefront of manufacturing best practices, technology trends and innovative solutions.

What is Required:

  • Relevant degree in Chemical Engineering, Pharmaceutical Sciences, Pharmaceutics, Industrial Pharmacy, or other life sciences related fields to include: Doctorate (Ph.D.) with 8+, Masters (M.S.) with 12+, or Bachelor (B.S.) with 15+ years of experience in Pharmaceutical industry.
  • Technical expertise in formulation design, process development, process scale-up and technology transfer of conventional and enabling solid oral dosage forms using FDA/ICH guidance and Quality by Design (QbD) principles such as DoE, statistical analysis, first principles, modeling, and FMEA/Risk Assessment tools.
  • Strong knowledge and hands-on experiences in conventional and enabling oral dose manufacturing unit operations such as: Dry/Wet Granulation, Milling, Blending, Compression, Film Coating, Spray Drying, Nano-Milling, and Twin Screw Extrusion.
  • Robust understanding of material science and linkage to manufacturing process and product performance. Experience in use of applied science during manufacturing troubleshooting, gap analysis, root cause analysis, and risk assessment.
  • Experience in authoring CMC sections of regulatory dossiers (including NDAs and MAAs) with proven track record. Knowledge of cGMP requirement for drug product development and manufacturing.
  • Hands-on experience in Process Validation (PPQ), and post approval changes according to FDA and ISPE guidelines. Experience in use of statistical tools in data trending for process performance characterization, process capability analysis, and CPV/CPI during product life cycle.
  • Excellent interpersonal skills with the ability to interact professionally and effectively with peers, management, and leadership both within and outside the company. Experience in project management and ability to work in a cross-functional working groups.
  • Excellent verbal and written communication skills with strong technical report writing.
  • Ability to travel up to 35% domestically and internationally.

Mirati's policy is to provide equal employment opportunities to all applicants and employees without regards 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 informations, 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.

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.

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