Principal Scientist, CMC Analytical

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee the analytical development and quality control strategy for one or more programs, establishing the technical direction for method development, validation, and lifecycle management to ensure reliable, phase-appropriate control of product quality.

• Collaborate with CDMO and contract laboratory partners as the primary technical liaison, steering the resolution of complex analytical or method-related challenges while ensuring partners adhere to scientific and quality standards.

• Direct the analytical method development, qualification, and validation for drug substances (APIs), including forced degradation, impurity profiling, and physicochemical characterization to support process understanding and specification establishment.

• Conduct thorough reviews and interpretations of analytical data (HPLC/UPLC, Dissolution, KF, GC, etc.) across release and stability programs, personally addressing the most complex or ambiguous data issues.

• Detect subtle trends, shifts, or anomalies in intricate data sets that could affect product quality, method robustness, or long-term stability, and translate findings into program-level risk assessments and recommendations for leadership.

• Act as the technical lead and ultimate scientific authority during OOS, OOT, and atypical result investigations, driving root cause analysis and ensuring scientifically sound, defensible conclusions.

• Take responsibility for the preparation and technical accuracy of the analytical development and quality control data packages that support regulatory submissions, authoring the CMC analytical sections of regulatory documents (e.g., NADA/INAD filings, briefing documents, and responses to health authority inquiries), ensuring that data and method documentation are complete, scientifically valid, and ready for submission.

• Mentor and provide technical guidance to junior scientists and analysts, enhancing analytical capabilities within the team.

⛳️ Requirements

• Ph.D. in Analytical Chemistry, Chemistry, Biochemistry, or a related discipline.

• Over 10 years of experience in QC laboratory operations and/or analytical method development with significant hands-on experience in small-molecule oral solid dosage forms. Sponsor-side pharmaceutical experience is strongly preferred; experience in animal health/veterinary fields is a plus.

• Extensive knowledge of analytical chemistry as it pertains to 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.

• Previous experience managing CDMO relationships, tech transfers, and Quality Control programs is desirable.

• Comprehensive understanding of cGMP, ICH/VICH, FDA, and EMA analytical expectations.

• Proven history of QC data interpretation and support for regulatory submissions.

• Innovative and analytical approach to resolving technical issues.

• Ability to swiftly grasp new concepts and processes.

• Flexibility, creativity, and high performance in risk assessment and strategic thinking.

• Willingness to work in and thrive within a fast-paced startup environment alongside a dynamic team.

• Excellent and concise communication skills.

🏝️ Benefits

• Comprehensive health insurance coverage — medical, dental, and vision — for you and your dependents.

• $1,000 stipend for home office equipment.

• $1,200 per year learning budget for books, courses, etc.

• $250 monthly wellness budget for gym memberships, cleaning services, spa visits, food, etc.

• All 3-day weekends transformed into 4-day weekends 🎉.

• Unlimited vacation and paid holidays.

• Paw-ternity leave — adopt a dog and receive a day off to bond with your new family member 🐶.

• Competitive salary.

• Company equity options grant for new hires.