Scientist II (LBA)

Responsibilities

• Serve as the Principal Investigator (PI), leading the design, development, validation, troubleshooting, and implementation of bioanalytical methods (e.g., ELISA, MSD, qPCR/RT-qPCR, flow cytometry) for both regulated and non-regulated pharmacokinetics, immunogenicity (ADA and Nab), and/or biomarker sample testing, data analysis and study reporting.
• Present and interpret data/results with scientific rigor and regulatory alignment, both internally and externally, ensuring clarity and accuracy.
• Collaborate effectively with clients, ensuring high satisfaction through timely communication, responsive service, and the on-schedule delivery of high-quality results.
• Draft, review, and finalize laboratory data and controlled documents, including bioanalytical study plans and reports.
• Support laboratory operations and provide mentorship and technical guidance to junior staff and collaborators.
• Represent the team in the development and continuous improvement of policies, procedures, work instructions, and standard operating procedures (SOPs).
• Ensure adherence to internal standards and regulatory requirements, including Code of Conduct, Environmental Health and Safety (EHS), GLP/GCP/GDP/21 CFR Part 11, and relevant guidelines from authority bodies like FDA and EMA. Perform other duties as needed.

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Skills, Education & Qualifications

• BA/BS or higher with 9-10 years lab experience; all experiences will be evaluated
• PhD in relevant field with 2-3 years industrial experience
• Knowledge and understanding of regulatory requirements; GLP, GCP, 21CFR Part 11, GDP, GMP
• Able to independently perform complex lab work
• Able to work in a regulated environment
• Able to work effectively and contribute within a team
• Able to work with computer systems
• Able to document clearly; knowledge of and experience in a regulatory environment