Associate Principal Scientist, Clinical Flow Cytometry

Job Description

Translational Molecular Biomarkers (TMB) is responsible for translating preclinical molecular biomarkers to clinical development across all therapeutic areas and all phases of clinical development at our Company's Research laboratories. TMB laboratories leverage a diverse array of technologies to develop biomarker assays to help confirm engagement of therapeutic targets and understand mechanisms of drug action and patient response.

Position Overview:

The Flow Cytometry group within TMB is seeking a highly motivated and skilled individual for the Associate Principal Scientist position. This role is vital for the development, validation, oversight, and troubleshooting of flow cytometric assays that are pivotal in supporting our clinical trials. The ideal candidate will possess robust technical and scientific expertise in flow cytometry, immunology, oncology, cell biology, and molecular biology, and show a strong interest in lab-based assay work. Additionally, the candidate should have experience collaborating closely with external partners to provide scientific and technical oversight for flow cytometric assays supporting our pipeline.

Key Responsibilities:

• Lead the transition of biomarker flow cytometry assays from Preclinical Research to Clinical Development.

  • Design, develop, and optimize flow cytometric assays across all therapeutic areas and clinical development phases.

  • Provide technical guidance on fit-for-purpose assay validation and troubleshoot assay and instrument-related issues.

• Collaborate and liaise with external partners and Contract Research Organizations (CROs) to manage the development, validation, and execution of flow cytometry assays.

  • Draft and review Statements of Work (SOWs), Workplans, Development Testing Agreements (DTAs), and Data Transfer Specifications (DTSs).

• Serve as a subject matter expert in flow cytometry, working with project teams, biomarker leaders, clinical operations, regulatory affairs, and physicians to implement assays and execute biomarker strategies for clinical trials.

• Prepare memos, final reports, and publications summarizing data and update lab Standard Operating Procedures (SOPs).

Position Qualifications:

Education Minimum Requirement:

• BS, BA, MS, or Ph.D. in a life sciences discipline (e.g., Biochemistry, Immunology, Cell Biology).

Required Experience and Skills:

• Experience: 13 years (BA/BS), 8 years (MS) and 3 years (PhD)

• Technical Expertise: Strong understanding of translational medicine and biomarker development with extensive knowledge and experience in flow cytometry techniques, including panel design, assay development, optimization, and validation.

• Instrument Expertise: Experience with flow cytometers (e.g., BD, Cytek) including maintenance, troubleshooting, and performance optimization.

• Data Analysis Skills: Proficient in data analysis and interpretation, using software tools such as FlowJo, OMIQ, and FCS Express, with the capability to derive actionable insights from complex datasets.

• Regulatory Knowledge: Understanding of regulatory guidelines (FDA, EMA) …