资深研究员-生物标志物项目（Qpcr平台）

该职位来源于猎聘 Labcorp is seeking a Senior Scientist
- Biomarker to join our team in Shanghai, China. Job

Responsibilities:
Lead biomarker and bioanalytical strategies for clinical programs Collaborate internally and with external sponsors as a biomarker lead Serves as a senior technical expert in bioanalytical laboratory activities. Responsible for executing and developing complex analytical methods, applying new technologies/platforms, solving advanced technical challenges, and guiding junior staff, while ensuring high-quality and compliant data generation. Acts as a technical mentor for junior and mid-level staff, providing hands-on guidance in complex experiments. Supports development of training materials or structured learning activities. Assists in identifying technical skill gaps within the team and provides coaching. May coordinate small groups during execution of complex workflows or new method implementation. Evaluates biomarker opportunities across all stages of drug development, balancing their scientific relevance (e.g., target engagement, mechanisms of action) with regulatory compliance guidelines Designs and establishes "fit-for-purpose" biomarker assay development and qualification frameworks to effectively support biomarker bioanalytical work in regulated environment Provides support for the Cell & Gene Therapy PIs on study-specific activities or tasks. Serves as a technical resource on the development of the Cell & Gene Therapy service. Monitor emerging trends and best practices in bioanalytical science, biomarker assay technologies, analytical platforms, and contribute to the implementation of innovative tools and approaches Strong laboratory experience and understanding of clinical and non-clinical biomarker assays. Executes advanced methods and workflows, including those based on new platforms or technologies. Independently leads to resolution of complex, non-routine, or ambiguous technical issues. Designs and perform troubleshooting experiments and identify root causes. Contributes to technology transfer and method transfer activities. Trains, mentors, and support junior and mid-level staff in laboratory techniques and troubleshooting. Acts as a go-to technical resource within the team. Provides input into technical approaches and experimental design discussions. Collaborates across teams to solve complex scientific problems. Ensures compliance with SOPs, GLP/GCLP, and regulatory standards. Identifies and escalates risks or deviations and supports CAPA implementation. Contributes to enhancing reproducibility, robustness, and data quality. Deep knowledge of PCR/ddPCR, and immunoassay platforms Demonstrate innovation and the capacity to learn and evaluate new biomarker techniques and methodologies. Participate in process improvement projects (e.g., SOPs, work instructions, training materials, etc.) for biomarker management Minimum Required: Bachelor Degree in biology, chemistry, pharmacy, and pharmaceutical analysis. 6 years of experience in biomarker assay. Preferred

Qualifications:
Proven ability to apply and implement new technologies or platforms, including method transfer and troubleshooting. Proven track record supporting biologics and Cell & Gene Therapy (CGT) programs through preclinical and IND-enabling stages Expertise developing and validating pharmacokinetics (PK), pharmacodynamics (PD), biodistribution, viral shedding, and immunogenicity (ADA) assays. Experience with regulated biomarker bioanalysis, including soluble proteins, gene expression, viral loading, and rare mutation detection. Demonstrated ability to resolve severe technical challenges such as assay instability, matrix effects, and low-abundance analyte isolation. Strong operational understanding of data integrity and regulatory requirements within GLP, GCP, and GCLP environments Experience interpreting complex datasets for cross-functional teams and mentoring junior laboratory staff Additional Job Standards: Strong method development and optimization capability Ability to apply and adapt new technologies/platforms Advanced troubleshooting and root cause analysis Strong data interpretation and scientific reasoning Independent problem-solving Technical mentoring and training Strong execution with scientific judgment Effective communication and collaboration