Sr Assoc. Scientist (Immunology & Environmental Testing)

Participates on a team of scientists in the development validation/verification continuous improvements and transfer of clinical immunology and environmental testing assays. The incumbent will work in a laboratory environment focusing on cellular immunology assays (specifically ELISPOT/) and environmental testing workflows including environmental microbiology endotoxin validation and trace analysis of environmental matrices.

This professional work a Tues-Sat (9A-6P) schedule out of our Memphis TN location.

• Experimental Design & Execution: Plans conducts and records results from moderately complex analysis development or research experiments within immunology (cellular assays ELISPOT) and environmental testing (microbiology trace analysis and endotoxin detection) areas.
• Protocol Adherence: Performs laboratory experiments following established protocols standard operating procedures (SOPs) and company procedures under GMP/QSR guidelines.
• Reporting & Documentation: Reports the status of assigned projects through the preparation of detailed technical reports validation summaries and documentation that clearly analyze and summarize experimental results particularly limits of detection (LOD) and quantification (LOQ) for trace assays.
• Data Analysis & Troubleshooting: Interprets results of immunology and environmental testing experiments performs microplate data analysis and makes recommendations for protocol or assay improvements. Identifies operational problems investigates experimental alternatives and implements recommended courses of action.
• Cross-Functional Collaboration: Works collaboratively with team members and other business units (including Lab Operations QA/QC R&D and Project Management) to support key site initiatives assay transfers and equipment qualification (IQ/OQ/PQ).
• Regulatory & Quality Compliance: Maintains strict adherence to operations product transfer project management and quality assurance standards preparing for and participating in laboratory inspections (e.g. CAP internal QA audits) as needed to meet department and project objectives.
• Supervision & Guidance: Works under general supervision receiving instructions on specific assignment objectives complex features and possible solutions. Assistance is provided on unusual problems and work is reviewed for the application of sound professional judgment.

Required Work Experience

• Minimum of 35 years of industry experience in a clinical biotechnology microbiology or environmental testing laboratory setting.
• 13 years of experience with an MS / MA degree in a relevant scientific discipline.
• Direct experience performing and troubleshooting ELISPOT or T-SPOT assays.
• Experience in an environmental microbiology or trace analysis laboratory setting specifically working with low-level contaminant detection.
• Hands-on experience with environmental monitoring and endotoxin testing methodologies (e.g. LAL recombinant cascade reagents kinetic/endpoint assays).
• Working knowledge of GMP/QSR regulations standard water testing methods (e.g. Heterotrophic Plate Counts) and laboratory accreditation standards (e.g. CAP inspections).
• Experience operating and qualifying microplate readers hematology analyzers and programming automated liquid handling platforms (e.g. Hamilton JANUS and/or Dynamic Devices platforms).
• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job the employee is frequently required to use hands to finger handle or feel objects tools or controls and reach with hands and arms in the operation of diagnostic equipment or automated instruments in the laboratory.
• The employee is frequently required to sit and stand; and is occasionally required to walk and stoop. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds.
• Specific vision abilities required by this job include close vision color vision (critical for visual assay evaluation) and depth perception.
• May require flexibility with working hours based on project requirements. Will require tracking weekly hours by activity/project(s).

• Scientific understanding of cellular immunology principles (T-cell responses cytokine release) and environmental microbiology (including waterborne pathogens and biofilm management).

Preferred Work Experience

Physical and Mental Requirements

Knowledge & Skills

• Scientific understanding of cellular immunology principles (T-cell responses cytokine release) and environmental microbiology (including waterborne pathogens and biofilm management).
• Theoretical and practical understanding of trace analysis concepts contamination control cleanroom behavior and assay sensitivity dynamics (LOD/LOQ).
• Knowledgeable in the use of common laboratory equipment (e.g. microtiter plate readers) and safe chemical/biological material handling.
• Requires a strong knowledge of related diagnostic products and validation technologies gained through developmental experience in an academic or industrial setting.
• Planning & Organization: Requires strong planning organization and communication skills to balance daily operational testing with ongoing validation projects.
• Ability to apply mathematical concepts to scientific problem-solving (e.g. dilution calculations standard curve generation trace recovery calculations and assay validation metrics).
• Ability to apply mathematical operations to tasks such as frequency distribution determination of test reliability/validity analysis of variance and correlation techniques.
• Communication: Ability to read and interpret scientific literature operating instructions standard operating procedures and regulatory guidelines. Excellent technical writing skills for report and correspondence generation. Ability to speak effectively in one-on-one and small group situations.

• Problem-Solving: Ability to apply common-sense understanding to carry out instructions furnished in written oral or diagram form and to independently troubleshoot multi-variable assay anomalies or trace contamination vectors.

Analytical & Mathematical Skills:

• Ability to apply mathematical concepts to scientific problem-solving (e.g. dilution calculations standard curve generation trace recovery calculations and assay validation metrics).
• Ability to apply mathematical operations to tasks such as frequency distribution determination of test reliability/validity analysis of variance and correlation techniques.
• Communication: Ability to read and interpret scientific literature operating instructions standard operating procedures and regulatory guidelines. Excellent technical writing skills for report and correspondence generation. Ability to speak effectively in one-on-one and small group situations.
• Problem-Solving: Ability to apply common-sense understanding to carry out instructions furnished in written oral or diagram form and to independently troubleshoot multi-variable assay anomalies or trace contamination vectors.

Education

Bachelors Degree: Requires knowledge and skills normally acquired through the completion of a Bachelors Degree in Microbiology Biology Molecular Biology Immunology Chemistry or a related scientific discipline (Required).