The Immunology and Immunochemistry disciplines support large molecule drug development using ligand binding assays, such as enzyme-linked immunosorbent assay, to measure large molecules and their immune responses. The main types of assays include Pharmacokinetic assays to measure drug and Immunogenicity assay to measure anti-drug antibodies and neutralizing antibodies. Other assay types also performed are branched DNA and cell-based assays. An array of platforms are used to support these assays that include spectrophotometer, Meso Scale Discovery, 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:
Effectively manage a portfolio of sample analysis projects while ensuring timelines are met in a single operational area with oversight
Execute review and approval of data with oversight for final scientific/technical decisions within a single operational area
Develop understanding of compliance expectations to respond to quality assurance audit observations in appropriate software with oversight
Assist with oversight the completion of laboratory investigations, assay troubleshooting and quality observations
Assist in problem solving for technical and/or regulatory issues with oversight; Responsible for writing and preparing study plans/protocols/amendments with minimal oversight; Participate in Sponsor visits/tours with minimal oversight
Develop expertise in developing and validating quantitative/qualitative methods/procedures with limited complexity/scope in one operational area with minimal oversight
Perform data analysis using appropriate software with minimal oversight
Develop critical thinking, troubleshooting and time management skills aligned with needs of operational areas
Demonstrate effective communication skills through informal discussions with peers, supervisor, and team
Function as a liaison, maintaining timely and frequent communication between CRL and Sponsor/Client/SD with minimal oversight
Ensure scientific integrity of studies with minimal oversight
Function as a Principal Investigator, Individual Scientist and/or Study Director as assigned with minimal oversight
Actively communicate and collaborate across operational areas in order to adhere to timelines and produce quality data
Efficiently perform and document all procedures, materials and results in compliance with applicable regulatory standards as applicable (protocols, methods, SOPs, etc.); Write, review and approve deviations with oversight
Develop knowledge of regulatory and GXP requirements, industry standards and company SOPs within one operational area
Effectively manage a small portfolio of research projects including method development and validation while ensuring timelines are met in a single operational area with oversight
Performs all other related duties as assigned
Bachelor's degree (BA/BS) with 5-7 years of relevant working experience. Master's degree (MS) with 1-2 years of relevant work experience. Doctorate degree (PhD) with no experience
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
