9 часов назад
Principal/Senior Scientist, PK/PD Assays
155 000 - 200 000$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Principal/Senior Scientist, PK/PD Assays (molecular biology and bioanalytical assays): Designing, developing, and qualifying PK/PD biomarker assays for mRNA-LNP medicines in preclinical and IND-enabling studies with an accent on pharmacokinetics, pharmacodynamics, and translational biomarker development. Focus on validating biomarkers, analyzing complex biological matrices, building audit-ready data packages, and establishing assay workflows and SOPs.
Location: South San Francisco, United States
Salary: $155,000–$200,000 per year
Company
is a biotechnology company developing medicines for age-related diseases by reprogramming the epigenome and restoring regenerative potential in aged and diseased cells.
What you will do
- Design, develop, and qualify PK and PD biomarker assays across multiple platforms for preclinical and IND-enabling studies.
- Discover and validate pharmacodynamic biomarkers supporting clinical development across multiple therapeutic programs.
- Analyze, interpret, and report bioanalytical study data in audit-ready packages for program decision-making.
- Contribute to tissue harvesting, primary cell culture, and complex biological matrix processing workflows.
- Mentor research associates, establish SOPs, and build institutional knowledge within the bioanalytical function.
Requirements
- PhD in molecular biology, biochemistry, cell biology, or a related field, or equivalent industry experience of 5+ years.
- 3+ years of hands-on experience with quantitative bioanalytical platforms such as RT-qPCR, ddPCR, ELISA, MSD, Olink, SOMAscan, or NGS-based methods.
- Experience working with complex biological matrices, including serum, plasma, and tissue homogenates.
- Strong knowledge of bioanalytical method qualification and validation principles for PK/PD biomarker measurements, including ICH M10 and fit-for-purpose frameworks.
- Experience with primary cell culture and tissue-derived sample workflows, including delivering bioanalytical projects and solving assay development challenges.
Nice to have
- Experience with bioanalytical method transfer and CRO management.
- Familiarity with preclinical drug development timelines and regulatory submissions, including IND, TGA, and CTD formats.
- Experience with mRNA-LNP biodistribution or nucleic acid-based PK assays.
- Experience developing gene therapy, nucleic acid therapy, or cell therapy products.
Culture & Benefits
- Comprehensive health, dental, and vision insurance.
- 401(k) plan with company match.
- Paid parental leave.
- 20 days of paid time off per year plus holidays.
- On-site meals and snacks.
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