Sr. Scientist, CMC Analytical at loyalhealth

, , United States -

Full Time

Start Date

Immediate

Expiry Date

20 Mar, 26

Salary

145000.0

Posted On

20 Dec, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Analytical Chemistry, Data Interpretation, Method Development, Quality Control, Regulatory Compliance, Small Molecule Testing, Problem Solving, Technical Analysis, Data Trending, cGMP, FDA Regulations, ICH/VICH Guidelines, Communication Skills, Adaptability, Creativity, Risk Assessment

Industry

technology;Information and Internet

Description

About Loyal Loyal is a clinical-stage veterinary medicine company developing drugs intended to extend the lifespan and healthspan of dogs. Our mission is to help dogs live longer, healthier lives. We’ve already achieved significant milestones on our path to earning FDA approval for the first lifespan extension drug for any species. We have three products in our pipeline and are on track for FDA conditional approval within the next year. Loyal is a well-funded startup in growth mode. Our team includes scientists, veterinarians, engineers, operators, and creatives. This role will play a key role in supporting our growth strategies. About the role We’re seeking an experienced Sr. Scientist, CMC Analytical to serve as the SME in analytical methods and data interpretation, providing advanced technical analysis of data generated during product release, stability testing, and method lifecycle activities. This role requires deep expertise in analytical method development, data trending and interpretation, with the ability to translate findings into actionable insights that inform quality decisions and regulatory strategy. 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. This role is for someone who applies strong technical judgment to ensure robust product understanding, reliable quality control performance, and continuous method improvement throughout clinical development and commercialization.This role is for someone who has extensive experience with method development for small molecule drug product and API testing particularly with new chemical entities. The ideal candidate should be able to critically review all data for potential trends or issues. Experience managing outside labs is a plus. You will be reporting to our Sr. Manager, CMC Analytical. Your daily work will include: Perform in-depth review and interpretation of analytical data (HPLC/UPLC, Dissolution, KF, GC, etc) across release and stability programs. Identify subtle trends, shifts, or outliers in complex data sets that may impact product quality, method robustness, or long-term stability. Provide expert technical input during OOS, OOT, and atypical result investigations, ensuring scientifically sound conclusions. Lead trending of release and stability data across programs, highlighting emerging quality signals and risks. Review and assess data from method development, transfer, qualification, and validation activities. Ensure Quality Control data packages are complete, scientifically defensible, and compliant with cGMP and regulatory expectations. About you: A Bachelor’s or Advanced degree (master’s or Ph.D.) in Analytical Chemistry, Chemistry, Biochemistry or a related field. Animal Health experience strongly preferred. 6+ years of experience in quality control laboratory, analytical or method development, with significant experience with small molecules preferred. Deep and broad knowledge of analytical chemistry in support of small molecule 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. Detailed eye for logistics and problem solving. Willing to work and comfortable in a fast-paced startup environment with a dynamic team. Clear and polite communication skills. Familiarity with Google Workspace applications (e.g., Sheets, Slides, etc.). Salary: $125,000 - $145,000 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 Loyal is founded and led by a first-gen female CEO and is proud to be an equal opportunity employer. We do not discriminate against applicants based on gender, race or color, ethnicity or national origin, age, disability, religion, sexual orientation, gender identity or expression, veteran status, or any other applicable characteristics protected by law. Our values Lean into moonshots We don’t settle for incremental change. We have the bravery to take risks and shoot for the impact we want to have. Opportunity is at the intersection We lean into combining disciplines, expertises, and perspectives not normally adjacent. We design our organization to facilitate cross-pollination and cross-collaboration. We reject silos. Expertise without ego Titles do not determine who has a voice. We work on hard technical problems and have a ton of fun while at it. Learning by doing Our path is novel and many things we are doing have never been done before. We lean into MVPs and are open to unexpected outcomes. Lead with context We value leading with context. We equip people with the context and background necessary to make their own decisions and act in the best interest of Loyal. We empower teams to succeed. Empathy and respect for all life Our patients are not just numbers. Our work is intentional, thoughtful, and guided by respect for life. We take our responsibility to pets and pet parents seriously.

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Responsibilities

The Sr. Scientist will perform in-depth reviews and interpretations of analytical data to ensure product quality and regulatory compliance. This role involves leading data trending and providing expert technical input during investigations of atypical results.