Seeking a highly motivated and skilled scientist with exceptional translational immunology, immuno-oncology and clinical trial background.
DUTIES AND RESPONSIBILITIES
Responsible for assay development, qualification and validation
Perform multi-parameter flow cytometry including panel design (>12 colors), instrument set-up, sample acquisition and data analysis
Perform multiplex cytokine assay such as Luminex and MSD and ELISA
Responsible for the quality and efficiency of studies performed in a regulated environment.
Project management: lead analysis of flow cytometry data using Flowjo, FACS Suite and Diva software and reporting of results.
Responsible for training internal staff or external collaborators on scientific processes
Responsible for scheduling and planning to effectively manage workload
Ensuring compliance with established standard operating procedures (SOP).
Ability to interact directly with customers
KNOWLEDGE, SKILLS, AND ABILITIES
Extensive experience with flow assay development, qualification and validation for clinical trials
Proficient in multi-parameter flow cytometry including panel design (>12 colors, instrument set-up, sample acquisition, data analysis)
Strong data analysis experience using Flowjo, Diva software and other FACS related analysis tools
Proficiency in the analysis and understanding of immune cells and molecules.
Perform ex vivo and in vitro assays for immuno-oncology relevant endpoints (e.g. ELISA and multiplex cytokine assays)
Preparation and handling of primary specimens, including peripheral blood, ascites, other liquid biospecimens.
Primary immune cell culture (experience with T cells, NK cells, Dendritic cells, Macrophages)
Sample preparation (murine or human tissues/cells) for immunostaining and acquisition by flow cytometry
Troubleshoot, optimize, and develop methods for unmet experimental needs
Maintain laboratory records and notebook, organize and compile data, and write weekly reports on results
Present data, compose manuscripts & prepare posters/presentations at national/international meetings or symposia in support of business objectives
Experience in data interpretation and statistical analysis.
Train internal staff or external collaborators on scientific processes.
Manage timelines and deliverables and develop reports for various projects.
Coordinate parallel tasks across multiple projects, demonstrating prioritization.
Strong planning, organizational, computer, written and verbal communication skills.
Demonstrated accountability and responsibility for own work.
Capable of high performance in independent work as well as in team setting.
EDUCATION AND EXPERIENCE
Ph.D. in immunology, cellular and/or tumor biology or a closely related field (3-10 year of experience)
GLP/GCLP and CAP/CLIA experience required
Extensive experience with validation of analytical methods per ICH Q2 guidelines
Must have experience in flow cytometry, immune cell phenotyping of immune cell subsets
Must have experience designing and developing flow cytometry panels for clinical trials
PHYSICAL DEMANDS AND WORK ENVIRONMENT
Must be able to sit and use hands to finger, handle and feel.
Must be able to lift and move packages weighing up to 50 pounds.
Must be able to sit for long periods of time using a computer in a typical office environment in a multi-level facility
Some activities require repetitive motion and reaching, pulling or pushing.
In carrying out the duties of the job there will be frequent exposure to fumes and chemical hazards.
Duties performed routinely require exposure to blood, body fluid and tissue.
This job description may be changed to include new responsibilities and tasks or change existing ones as management deems necessary.