1 день назад
Senior Scientist (Drug Product Analytical Development)
162 000 - 186 000$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Senior Scientist (Drug Product Analytical Development): Developing and managing analytical methods, validation, stability programs, and control strategies for drug product formulations with an accent on amorphous solid dispersions, lipid-based systems, and regulatory submissions. Focus on overseeing CDMO/CRO testing, analyzing stability trends, supporting PPQ and commercialization, and authoring IND/IMPD/NDA documentation.
Location: Onsite at Nurix headquarters in Brisbane, California, United States. Travel up to 5% may be required.
Salary: $162,000–$186,000 per year.
Company
is a clinical-stage biopharmaceutical company developing targeted protein degradation medicines for oncology and inflammatory diseases.
What you will do
- Lead analytical method development, validation, and lifecycle management for drug product formulations, including amorphous solid dispersions and lipid-based systems.
- Design and oversee development, registration-batch, and commercial stability programs, including protocols, trend analysis, retest periods, and shelf-life evaluations.
- Provide technical oversight of analytical development, validation, and QC testing performed by CDMOs and contract testing laboratories.
- Support PPQ, commercialization, commercial QC, tech transfer, and analytical control strategy activities.
- Author and review analytical development reports, specifications, validation and stability documents, certificates of analysis, and regulatory submission sections.
- Contribute to investigations, root-cause analyses, CAPAs, data integrity, inspection readiness, and responses to health authority requests.
Requirements
- Advanced degree in Chemistry, Pharmaceutics, or a related discipline.
- BS/MS with 14+ years or PhD with 8+ years of industrial CMC experience.
- Strong experience in drug product analytical development and validation, including chromatographic and dissolution methods.
- Experience with amorphous solid dispersions and/or lipid-based formulations, CDMO oversight, and contract testing laboratories.
- Experience supporting IND, IMPD, NDA, and global regulatory filings.
- Fluency with ICH guidelines, cGMP requirements, pharmacopeial chapters, technical writing, and cross-functional collaboration.
Culture & Benefits
- Work as part of multidisciplinary teams spanning Chemical Development, Pharmaceutical Development, Regulatory, Quality, Preclinical, Supply Chain, Medicinal Chemistry, and DMPK.
- Support oncology and inflammation and immunology development programs in a clinical-stage biopharmaceutical environment.
- Maintain analytical documentation and data for traceability, data integrity, and inspection readiness.
- Follow cGMP requirements and internal SOPs while managing multiple priorities in a fast-paced setting.
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