Principal Scientist/Engineer, Product Development
Department: Technical Operations / CMC
Employment Type: Full Time
Reference Number: 1894989
Job Description Summary
The Principal Scientist/Engineer, Product Development will lead process scale-up, tech-transfer, and packaging design of oral dosage forms at external contract development & manufacturing organizations (CDMO's). He/she will serve as a subject matter expert in product development related activities for new product introductions, routine commercial production, and product lifecycle. He/she will work effectively with cross-functional groups, including analytical development, process chemistry, clinical, quality, regulatory, and supply chain to enable activities related to Process Validation, Commercial Launch, and Post-Approval changes using sound science and in compliance with all applicable GMP/ICH regulations and corporate procedures.
- Technical lead for process development activities leading to commercial product launch readiness including process validation (PPQ) and equipment qualification (IQ/OQ/PQ).
- Lead process scale-up and tech-transfer of various pharmaceutical unit operations, including post-approval changes by using first principles, process modeling, Design of Experiments (DoEs), and statistical analysis under Quality by Design (QbD) paradigm.
- Lead 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.
- Late stage drug product Subject Matter Expert for oral solid dosage unit operations, providing technical leadership during troubleshooting of ongoing drug product manufacturing at CDMO.
- Lead screening, selecting, and managing drug product manufacturing sites/technologies (CDMOs) of oral solid dosage drug products.
- Review and approve batch records, protocols and technical reports.
- 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.
- Author high-quality process technology transfer and other technical documents, and participate in authoring relevant sections of regulatory submissions.
- Perform raw material, manufacturing processes and site-based FMEA and risk assessment from early stage process development to late stage commercialization.
- 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
- Doctorate (Ph.D.) in Chemical Engineering, Pharmaceutical Sciences, Industrial Pharmacy, or other life sciences related fields with 8+, Masters (M.Sc.) with 12+, or Bachelor (B.S.) with 15+ years of relevant experiences in Pharmaceutical industry.
- Fundamental knowledge in process development, process scale-up and technology transfer of solid oral dosage forms at CDMOs using QbD principles and FDA/ICH guidance.
- Experience in packaging/shipment design, development, and validation of solid oral dosage forms.
- Technical expertise and hands-on experiences in conventional oral dose manufacturing unit operations such as: Dry/Wet Granulation, Milling, Blending, Compression, and Film Coating.
- Experience with enabling formulation and process technologies such as Spray Drying and Hot Melt Extrusion is a plus.
- Enriched experiences in Process Validation (PPQ), equipment qualification (IQ/OQ/PQ), and post approval changes according to FDA and ISPE guidelines.
- Expertise in use of first principles, statistical analysis, modeling, and data trending for process performance characterization, process capability analysis, and CPV/CPI during product lifecycle.
- Experience in authoring CMC sections of regulatory documentation (IND, NDA, MAA).
- Experience in manufacturing troubleshooting using of applied science in gap analysis, root cause analysis, and risk assessment.
- 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 35% 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.