Principal Scientist, CMC Analytical

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🇺🇸 United States – Remote

💵 $150k - $190k / year

⏰ Full Time

🔴 Lead

🧬 Research Scientist

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Loyal

WebsiteLinkedInAll Job Openings

51 - 200 employees

⚕️ Healthcare Insurance

🤖 Artificial Intelligence

☁️ SaaS

Healthcare Insurance • Artificial Intelligence • SaaS

Loyal is a comprehensive digital healthcare platform that integrates various touchpoints for patients and providers. Their solutions include data management, digital engagement, CRM campaigns, self-scheduling, and conversational AI, which are designed to optimize healthcare operations, improve patient engagement, and enhance care search and scheduling. Loyal focuses on making healthcare seamless by unifying provider and location data, managing reputation and directory listings, and offering robust machine learning and natural language processing capabilities to improve healthcare outcomes. The platform facilitates improved communication and retention through omni-channel engagement and feedback analysis, serving prominent healthcare organizations to streamline operations and drive better patient experiences.

📋 Description

• Lead the analytical development and quality control strategy for one or more programs, setting the technical direction for method development, validation, and lifecycle management to ensure robust, phase-appropriate control of product quality. • Partner with CDMO and contract laboratory partners as the primary technical point of contact, driving resolution of complex analytical or method-related issues and holding partners accountable to scientific and quality standards. • Lead drug substance (API) analytical method development, qualification, and validation, including forced degradation, related substances/impurity profiling, and physicochemical characterization to support process understanding and specification setting. • Perform in-depth review and interpretation of analytical data (HPLC/UPLC, Dissolution, KF, GC, etc) across release and stability programs, and personally lead the resolution of the most complex or ambiguous data issues. • Identify subtle trends, shifts, or outliers in complex data sets that may impact product quality, method robustness, or long-term stability, and translate findings into program-level risk assessments and recommendations for leadership. • Serve as the technical lead and final scientific authority during OOS, OOT, and atypical result investigations, driving root cause determination and ensuring scientifically sound, defensible conclusions. • Own preparation and technical accuracy of the analytical development and quality control data packages supporting regulatory submissions, and author the CMC analytical sections of regulatory documents (e.g., NADA/INAD filings, briefing documents, and responses to health authority questions), ensuring data and method documentation are complete, scientifically sound, and submission-ready. • Mentor and provide technical guidance to junior scientists and analysts, building analytical capability across the team.

🎯 Requirements

• Ph.D. in Analytical Chemistry, Chemistry, Biochemistry or a related field. • 10+ years in QC laboratory operations and/or analytical method development with substantial hands-on experience in small-molecule oral solid dosage products. Sponsor-side pharma experience strongly preferred; animal health/veterinary experience a plus. • Deep and broad knowledge of analytical chemistry in support of small molecule drug substance and drug product analytical development and quality control, including release and stability method development, raw material control, in-process control, and characterization. • Prior experience managing CDMO relationships, tech transfer, and Quality Control programs desired. • Deep understanding of cGMP, ICH/VICH, FDA, and EMA analytical expectations. • Proven track record of QC data interpretation and support of regulatory filings. • Creative and thoughtful approach to problem solving technical issues. • Ability to quickly learn new concepts and processes • Adaptability, creativity and high-performer in risk-assessment and strategic thinking • Willing to work and comfortable in a fast-paced startup environment with a dynamic team • Clear and concise communication skills

🏖️ Benefits

• Full-coverage health insurance — medical, dental and vision — for you and your dependents • $1,000 home office equipment stipend • $1,200/year learning budget for books, courses, etc. • $250/month wellness budget for gym, cleaners, spa, food, etc. • All 3-day weekends are turned into 4-day weekends 🎉 • Unlimited vacation and paid holidays • Paw-ternity leave — adopt a dog and get a day off with your new family member 🐶 • Competitive salary • Company equity options grant for new hires