Job Summary

We are seeking an Research Analyst 1 for our Immunochemistry at the site located in Mattawan, MI.

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 assay 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 that include spectrophotometer, Meso Scale Discovery (MSD), Luminex and Gyrolab. Utilizing these platforms/assays, the teams are responsible for the method development, validation and routine sample analysis in both the regulated and non-regulated space of non-clinical and clinical studies.

Essential Functions (The fundamental Duties & Responsibilities of the role (products and services provided/results accomplished) include, but are not limited to, those listed:

• Efficiently perform and document all procedures, materials and results in compliance with applicable regulatory standards as applicable (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 needs of the operational area
• 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
• Performs all other related duties as assigned

Job Qualifications

Qualifications (Knowledge, Experience, Skills and Abilities required to accomplish the essential functions) include but are not limited to:

• Minimum of a Bachelor's degree (BA/BS) or equivalent experience. No previous experience required.
• An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
• 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, but not limited to evenings, weekends, extended shifts, and/or extra shifts; sometimes on short notice.
• Ability to work under specific time constraints.