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Sr. Scientist, CMC Analytical

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Loyal

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Location:
United States

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Category:
Research and Development

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Contract Type:
Not provided

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Salary:

125000.00 - 145000.00 USD / Year
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Job Description:

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.

Job Responsibility:

  • 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

Requirements:

  • 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.)
What we offer:
  • 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

Additional Information:

Job Posted:
January 03, 2026

Employment Type:
Fulltime
Work Type:
Remote work
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