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.
Requirements
Ph.D. in a scientific discipline with 5 years of experience in biotechnology or pharmaceutical laboratory is required.
Key Skills and Expertise
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.
Personal Qualities
Demonstrate adaptability and a willingness to support changing priorities and evolving departmental needs.
Highly organized, detail-oriented, and computer proficient to handle related scientific tasks.
Ability to work independently in a fast-paced work environment and prioritize several projects with minimal supervision.