PK/ADA Scientist

About the role

As a PK/ADA Scientist you will provide technical and scientific expertise in the required assay area (e.g., spectrophotometry, chromatography, ligand binding assay, flow cytometry, molecular biology) for method development, validation/qualification and execution of analytical projects in support of preclinical /clinical studies. What You'll Do Here Accountability for planning and managing timeline of assigned projects. Review analytical data to ensure accuracy, completeness, consistency and regulatory compliance. Respond to client inquires as needed to assist in study and assay design. Provide scientific guidance and participate in the validation/qualification of new and current methods that are used in support of preclinical/clinical studies Prepare and modify SOPs as needed. Provide indirect or direct line supervision of laboratory staff as assigned. Maintain laboratory equipment, reagents and expendables inventory. Design and execute appropriate analytical procedures; critically review data and write study reports. Serve as Responsible/Contributing Scientist/Principal Investigator on GLP studies and as scientific resource for junior staff, peers and Study Directors. Interact with clients through execution of analytical projects and provide on-time communication. Work with departmental management to sustain analytical businesses with good science and regulation compliance. What You'll Need to Succeed Minimum 3-5 years of hands on experience conducting method development, validations, sample analysis, under PK and ADA assays in a GLP environment. BS, MS, or PhD in biological, pharmaceutical science or related field, or an equivalent combination of education and experience in performing laboratory-based assays related to immunology, molecular biology, and/or cell biology/ biochemistry/chemistry. Rigorous attention to detail, excellent communication skills and ability to work effectively on interdisciplinary teams of Study Directors, Quality Assurance, and other departmental personnel. Strong schedule and work management skills to perform contracted projects according to the timeline. Excellent data analysis skills and ability to critically review data for scientific/technical merit and accuracy. Excellent communication skill to interact with clients and possible clients, and ability to understand and conduct work under appropriate regulatory requirements.