Research Analyst I, Bioanalysis LBA

Job Overview

The Immunology and Immunochemistry disciplines support large molecule drug development using ligand binding assays (LBA), such as enzyme-linked immunosorbent assay (ELISA), to measure large molecules and their immune responses. The main types of assays include Pharmacokinetic (PK) assays to measure drug and Immunogenicity assays to measure anti-drug antibodies (ADA) and neutralizing antibodies (NAb). Other assay types also performed are branched DNA (bDNA) and cell-based assays.

An array of platforms are used to support these assays:

• Spectrophotometer
• Meso Scale Discovery (MSD)
• Luminex
• Gyrolab

Utilizing these platforms/assays, the teams are responsible for the method development, validation, and routine sample analysis in both regulated and non-regulated environments for non-clinical and clinical studies.

Key Responsibilities

• Efficiently perform and document all procedures, materials, and results in compliance with applicable regulatory standards (protocols, methods, SOPs, etc.).
• Demonstrate effective communication skills through informal discussions with peers, supervisor, and team.
• Assist with laboratory maintenance functions.
• Independently perform laboratory support functions such as labeling and solution preparations.
• Assist with maintaining study-specific inventory of consumables with oversight.
• Write both study and non-study deviations with minimal oversight.
• Actively participate in process improvement initiatives with oversight.
• Develop critical thinking, troubleshooting, and time management skills aligned with operational area needs.
• Assist in execution of routine sample analysis studies with oversight.
• Assist in execution of method validation projects with oversight as needed.
• Operate laboratory instruments with complete oversight.
• Assist with data analysis in appropriate software for at least one analytical platform.
• Perform all other related duties as assigned.

Qualifications

• Minimum of a Bachelor's degree (BA/BS).
• No previous experience required.
• Ability to communicate verbally and in writing at all levels inside and outside the organization.
• Basic familiarity with Microsoft Office Suite.
• Computer skills, commensurate with Essential Functions, including the ability to learn a validated system.
• Ability to work extended hours beyond normal work schedule to include evenings, weekends, extended shifts, and/or extra shifts, sometimes on short notice.
• Ability to work under specific time constraints.
• Must be authorized to work in the United States without a sponsor visa, now or in the future.

Workplace Requirements

• Ability to perform general office and/or laboratory procedures, including talking, hearing, standing or sitting for long periods, typing/entering data into a computer, using appropriate instruments, reaching with hands and arms, and wearing safety equipment (PPE).
• Specific vision abilities required: close vision, color vision, depth perception, and the ability to adjust focus.
• May be required to wear protective clothing (goggles, face shield, surgical mask, cap, gloves, scrubs, boots).
• May work near toxic or caustic chemicals, with biohazards, and/or with live animals.
• May be exposed to fumes or airborne particles, unpleasant odors, and/or wet, humid, and/or extreme temperature conditions.