Principal Scientist, Product Development
Remote, CA 92121 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).
- 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.
**CO candidates may not be considered
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