10 дней назад
Senior Scientist II - Biomarker
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Scientist II - Biomarker (Bioanalysis/Cell & Gene Therapy): Leading biomarker and bioanalytical strategies for clinical programs, developing complex assays, and supporting regulated laboratory workflows with an accent on PCR/ddPCR, immunoassays, and method qualification. Focus on solving advanced technical issues, transferring methods, interpreting complex data, and mentoring laboratory staff while ensuring GLP/GCLP compliance and data quality.
Location: SIMZ Pudong, Shanghai, China
Company
provides laboratory services, diagnostics, data, and technology solutions for healthcare providers, researchers, pharmaceutical companies, and health systems.
What you will do
- Lead biomarker and bioanalytical strategies for clinical programs and collaborate with internal teams and external sponsors.
- Design, develop, qualify, and optimize complex biomarker assays and fit-for-purpose bioanalytical frameworks.
- Execute advanced workflows using PCR, ddPCR, immunoassay, and emerging analytical platforms.
- Resolve complex technical issues through troubleshooting experiments, root-cause analysis, and data interpretation.
- Support biologics and Cell & Gene Therapy programs, including technology transfer and method transfer activities.
- Mentor junior and mid-level staff, coordinate complex workflows, and contribute to training and process improvement.
Requirements
- Bachelor’s degree in biology, chemistry, pharmacy, pharmaceutical analysis, or a related field.
- At least 6 years of experience in biomarker assays.
- Strong laboratory experience with clinical and non-clinical biomarker assays, including PCR/ddPCR and immunoassay platforms.
- Experience with method development, optimization, qualification, validation, transfer, and advanced troubleshooting.
- Knowledge of GLP, GCP, GCLP, SOPs, regulatory requirements, data integrity, risk escalation, and CAPA.
- Ability to independently solve complex technical problems, interpret complex datasets, communicate effectively, and mentor laboratory staff.
Nice to have
- Experience supporting biologics and Cell & Gene Therapy programs through preclinical and IND-enabling stages.
- Expertise in PK, PD, biodistribution, viral shedding, and immunogenicity assays.
- Experience with soluble proteins, gene expression, viral loading, rare mutation detection, matrix effects, and low-abundance analytes.
Culture & Benefits
- Work in a global laboratory services and healthcare environment.
- Contribute to diagnostic, pharmaceutical, and clinical research programs.
- Participate in scientific innovation, technology implementation, and process improvement.
- Equal opportunity workplace with an inclusive and non-discriminatory employment policy.
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