Senior Scientist II-Biomarker

Labcorp is a global leader in laboratory services providing the insights and answers that help healthcare providers patients researchers pharmaceutical companies and health systems make confident decisions and improve outcomes. Through our unparalleled science data technology and laboratory network we advance diagnostics accelerate innovation and help address some of the worlds most important health challenges. As we shape the future of healthcare we are leveraging advanced technologies intelligent digital solutions and data-driven innovation across our operations to enhance how work gets done and deliver greater value to customers and patients. With our global scale and deep expertise youll have the opportunity to do meaningful work grow your career and make a real impact on peoples health around the world. Together were improving health and improving lives.

Senior Scientist II- Biomarker

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

Labcorp is proud to be an Equal Opportunity Employer:

Labcorp strives for inclusion and belonging in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications and merit of the individual. Qualified applicants will receive consideration for employment without regard to race religion color national origin sex (including pregnancy childbirth or related medical conditions) family or parental status marital civil union or domestic partnership status sexual orientation gender identity gender expression personal appearance age veteran status disability genetic information or any other legally protected characteristic. Additionally all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law.

We encourage all to apply

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