15 часов назад
Principal Scientist, CMC Analytical (Veterinary Pharmaceuticals)
150 000 - 190 000$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Principal Scientist, CMC Analytical (Veterinary Pharmaceuticals): Leading analytical development and quality control for oral solid veterinary drug products with an accent on method development, validation, stability testing, and regulatory data packages. Focus on interpreting complex HPLC/UPLC, dissolution, KF, and GC data, resolving OOS/OOT investigations, and authoring CMC analytical sections for FDA submissions.
Location: Remote - US
Salary: $150,000–$190,000 per year
Company
is a well-funded clinical-stage veterinary medicine startup developing longevity drugs intended to help dogs live longer, healthier lives.
What you will do
- Lead analytical development and quality control strategy for one or more oral solid dosage drug programs.
- Direct method development, qualification, validation, and lifecycle management for drug substance and drug product testing.
- Partner with CDMOs and contract laboratories to resolve complex analytical issues and maintain scientific and quality standards.
- Review and interpret release and stability data from HPLC/UPLC, dissolution, Karl Fischer, GC, and related methods.
- Lead OOS, OOT, and atypical result investigations, including root-cause analysis and risk assessment.
- Prepare analytical development and quality control data packages and author CMC analytical sections for NADA/INAD filings, briefing documents, and health authority responses.
Requirements
- Ph.D. in Analytical Chemistry, Chemistry, Biochemistry, or a related field.
- 10+ years of experience in QC laboratory operations and/or analytical method development, including hands-on work with small-molecule oral solid dosage products.
- Deep knowledge of analytical chemistry, release and stability testing, raw material and in-process controls, impurity profiling, forced degradation, and physicochemical characterization.
- Strong understanding of cGMP, ICH/VICH, FDA, and EMA analytical expectations.
- Proven experience interpreting QC data and supporting regulatory filings.
- Strong communication, problem-solving, adaptability, and strategic risk-assessment skills in a fast-paced startup environment.
Nice to have
- Sponsor-side pharmaceutical experience.
- Animal health or veterinary experience.
- Experience managing CDMO relationships, technology transfer, and quality control programs.
Culture & Benefits
- Health insurance covering medical, dental, and vision care for employees and dependents.
- $1,000 home-office equipment stipend and a $1,200 annual learning budget.
- $250 monthly wellness budget.
- Unlimited vacation, paid holidays, and extended four-day weekends for three-day weekends.
- Paid paw-ternity leave for dog adoption and company equity options for new hires.
- Collaborative, transparent, interdisciplinary culture focused on rigorous experimentation, humility, and respect for all life.
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