Senior Scientist, Analytical Sciences

Role Summary

Senior Scientist, Analytical Sciences with expertise in bioassays, including cell-based assays using different cell types and detection formats, qPCR, and ELISA. Responsible for performing non-GMP in-house bioassay method development and testing, while supporting and overseeing method development, and GMP testing at external laboratories. This is an individual contributor role based onsite in Cambridge, MA.

Responsibilities

• 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.

Qualifications

• Required: Ph.D. in a scientific discipline with 5 years of experience in biotechnology or pharmaceutical laboratory.
• Required: Strong expertise including hands-on experience with cell-based assays, ELISA, and qPCR.
• Preferred: Experience with microbiological tests.
• Required: Robust understanding of regulatory guidance and industry standards relevant to bioassay related CMC activities, particularly in the development and validation of bioassays.
• Required: Strong scientific, analytical problem solving and communication skills.
• Required: Demonstrate adaptability and a willingness to support changing priorities and evolving departmental needs.
• Required: Highly organized, detail-oriented and computer proficiency to handle related scientific tasks.
• Required: Ability to work independently in a fast paced work environment and prioritize several projects with minimal supervision.
• Preferred: Flexibility to travel to CTLs/CMOs on an as needed basis.