About the roleWe're seeking an experienced Principal Scientist, CMC Analytical to serve as the analytical lead/subject matter expert in analytical development for oral solid dosage products. This role provides advanced technical analysis of drug substance and drug product data across release testing, stability testing, and method lifecycle management, and translates findings into actionable insights that inform quality decisions and regulatory strategy. Success requires deep expertise in analytical method development and validation, strong data trending and interpretation skills, and demonstrated regulatory authoring experience.
Your work will ensure that robust, phase-appropriate analytical methods and data packages support product quality, regulatory compliance, and successful advancement of therapies from early development through commercialization.
You will be reporting to our Senior Director, Analytical Development
Your daily work will include:- 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.
About you:- 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 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 outsourced analytical programs (development and/or QC), CDMO relationships, 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
Salary Range: $150,000 - $190,000
Loyal 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
