2 дня назад
Principal Scientist, Immunogenicity and Ligand Binding Assays (mRNA-LNP)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Principal Scientist, Immunogenicity and Ligand Binding Assays (mRNA-LNP): Leading regulated immunogenicity and ligand binding assay bioanalysis for Moderna's mRNA-LNP therapeutic pipeline with an accent on assay development, validation, clinical sample analysis, and regulatory support. Focus on designing phase-appropriate bioanalytical strategies, overseeing ADA and neutralizing antibody assays, and ensuring GcLP, GLP, and GCP compliance.
Location: Oxford, England, United Kingdom; follows a 70/30 work model with 70% in-office collaboration.
Company
develops mRNA medicines through its mRNA technology platform and therapeutic pipeline.
What you will do
- Provide scientific and hands-on oversight of ligand binding assay bioanalysis for mRNA-LNP therapeutic development programs.
- Design and execute phase-appropriate, risk-based clinical bioanalytical strategies across clinical development stages.
- Lead regulated development, validation, and clinical sample testing for anti-drug antibody and neutralizing antibody assays.
- Drive development and implementation of cell-based assays, immunoassays, translated-protein quantitation, PK assays, and PD assays.
- Review analytical data, validation results, and study reports to ensure scientific integrity, data quality, and regulatory compliance.
- Collaborate with internal and external stakeholders, contribute to regulatory submissions, and support responses to regulatory authorities.
Requirements
- Ph.D. in infectious disease, immuno-oncology, immunology, cancer biology, or a related field, plus 10+ years of industry biotechnology or pharmaceutical experience; an M.S. with extensive bioanalytical experience may be considered.
- Experience with clinical assay platforms including ECL, Gyrolab, reporter gene assays, DELFIA assays, and related methodologies.
- Knowledge of GLP requirements, regulatory expectations, and current bioanalytical industry practices.
- Ability to communicate scientific concepts, program objectives, and data analysis in a matrix environment.
- Experience with RNA, biologics, and cell therapy is preferred.
- Experience with Watson LIMS and LabVantage eLBN is advantageous.
Culture & Benefits
- In-person collaboration model emphasizing innovation, teamwork, and direct mentorship.
- Healthcare coverage and voluntary benefit programs.
- Fitness, mindfulness, and mental health support.
- Family-building benefits, including fertility, adoption, and surrogacy support.
- Paid vacation, bank holidays, volunteer days, sabbatical, global recharge days, and year-end shutdown.
- Savings and investment programs, with additional location-specific benefits.
Будьте осторожны: если работодатель просит войти в их систему, используя iCloud/Google, прислать код/пароль, запустить код/ПО, не делайте этого - это мошенники. Обязательно жмите "Пожаловаться" или пишите в поддержку. Подробнее в гайде →
Похожие вакансии
19 часов назад
Lead Scientist – Potency, ELISA & Cell-Based Analytics (Biotech)
21 час назад
Principal Scientist, Pharmaceutical Development
1 день назад
Scientist II (Cell Culture and Assay Development)
38 600 - 46 500GBP
1 день назад
Senior Technical Specialist - DMPK
10 часов назад
Associate Scientist (Laboratory)
3 дня назад