Aerotek Assay Development Lab Technician/Associate in Gaithersburg, Maryland
Essential Functions Performs research and/or development in collaboration with others for projects. Involved in bioanalytical assay development, qualification and validation, as well as testing of pharmacokinetic (PK) and Immunogenicity (ADA) samples from nonclinical and clinical studies, in compliance with GLP/GCLP regulations.
Responsibilities • Perform routine and non-routine tests and analyses using the appropriate technical equipment and instruments • Operate and perform user maintenance of laboratory equipment in compliance with GLP requirements • Conduct assay qualification and validation studies following protocols • Perform testing of nonclinical and clinical PK and ADA samples following established assay procedures • Compile assay data, prepare summaries and assist in writing bioanalytical reports • Maintain timely and accurate data reporting - record assay development, validation and implementation work in accordance with principles of good documentation practices (GDP) as outlined in company’s SOPs and policies • Complete periodic GLP training and follow company’s SOPs and policies to comply with quality requirements
ELISA, Immunoassay, Bioanalytical assay, Cell based assay, Mammalian Cell Culture, Western Blot, GLP, Assay Qualification, Assay Validation
Top Skills Details:
ELISA Immunoassay MSD GLP
Additional Skills & Qualifications:
Qualifications • Associate's or Bachelor's degree in a biological science discipline • 1-2 years of experience performing biochemical/immunochemical assays, including ELISA methodology, is required • Ability to perform routine tasks accurately, following established assay procedures for handling and testing bioanalytical samples and operating laboratory equipment • Experience working in a GLP/GCLP environment is desirable • Computer skills: knowledge of Microsoft Office and other relevant computer programs • Strong attention to detail • Ability to write correspondence and reports • Excellent written and verbal communications are essential
We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.