Principal Scientist, CMC Analytical

Job not on LinkedIn

🕒 July 14

🇺🇸 United States – Remote

💵 $150k - $190k / year

⏰ Full Time

🔴 Lead

🧬 Research Scientist

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 23%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Loyal

WebsiteLinkedInAll Job Openings

51 - 200 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

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. • Partner with CDMO and contract laboratory partners as the primary technical point of contact, resolving complex analytical or method-related issues. • Lead drug substance analytical method development, qualification, and validation, including forced degradation, impurity profiling, and physicochemical characterization. • Review and interpret analytical data from HPLC/UPLC, dissolution, KF, GC, and other methods across release and stability programs. • Identify trends, shifts, and outliers affecting product quality, method robustness, or long-term stability, and provide risk assessments and recommendations. • Serve as technical lead and final scientific authority during OOS, OOT, and atypical result investigations. • Prepare analytical development and quality control data packages for regulatory submissions. • Author CMC analytical sections of regulatory documents, including NADA/INAD filings, briefing documents, and responses to health authority questions. • Mentor and provide technical guidance to junior scientists and analysts. • Report to the Senior Director, Analytical Development.

🎯 Requirements

• Ph.D. in Analytical Chemistry, Chemistry, Biochemistry or a related field. • 10+ years in 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 supporting 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 outsourced analytical programs, CDMO relationships, and tech transfer desired. • Deep understanding of cGMP, ICH/VICH, FDA, and EMA analytical expectations. • Proven track record of data interpretation and support of regulatory filings; experience authoring analytical sections of regulatory filings desired. • 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