Senior Scientist, Analytical Sciences

Perform and oversee cell based assays including ELISA and qPCR as well as microbiology tests. Lead feasibilities, development and transfers for cell based assays internally and externally, building and maintaining key relationships at CTLs. Apply deep knowledge of regulatory guidelines (ICH, USP chapters) to ensure compliance in bioassay development and validation as well as data verification. Provide bioassay technical leadership within assigned programs and offer guidance across other programs as needed. Draft, review and/or approve protocol, reports, certificates of testing. Record results of analysis in electronic notebook and/or in appropriate documentation method. Participate in cross-functional training and facilitate continuous improvement. Provide training and mentorship to colleagues and junior scientists within this area of expertise. Ph.D. in a scientific discipline with 5 years of experience in biotechnology or pharmaceutical laboratory is required. Strong expertise including hands-on experience with cell-based assays, ELISA, and qPCR. Experience with microbiological tests preferred. Robust understanding of regulatory guidance and industry standards relevant to bioassay related CMC activities, particularly in the development and validation of bioassays. Strong scientific, analytical problem solving and communication skills are required. Demonstrate adaptability and a willingness to support changing priorities and evolving departmental needs Highly organized, detail-oriented and computer proficiency to handle related scientific tasks. Ability to work independently in a fast pace work environment and prioritize several projects with minimal supervision.