Potency Bioassay Scientist

Eurofins USA PSS Insourcing Solutions•Boston, MA

2d•Onsite

About The Position

The Analytical Development team is responsible for developing and implementing new analytical methods, applying current methods and optimizing and improving current methods for the characterization of raw materials, RNA drug substances, and LNP products and programs at various developmental stages. We are seeking a highly skilled, passionate, and motivated Research Associate / Senior Research Associate to join our Analytical Development team to support analytical development and testing of non-GMP samples for development studies such as comparability assessments, process development, stability, product, and process characterization. This role is part of a Technical Operations team that partners closely with Quality Control, Quality Assurance, Process Development, and Analytical Research & Development with aims to advance preclinical gene editing candidates into the clinic and support our growing gene editing pipeline.

Requirements

B.S. degree in biological or biochemical sciences (or related field) with 1+ years of relevant laboratory experience.
M.S. degree in biological or biochemical sciences (or related field) with relevant laboratory experience.
Experience in sterile tissue culture technique and mammalian cell line maintenance including cell handling, passaging, seeding and banking.
Experience with bioanalytical methods such as cell-based functional assays and ELISA (experience with handling protein, DNA and RNA, and molecular biology assays is a plus).
Experience working with various analytical instrumentation such as cell counters, ELISA platforms, and plate readers.
Experience with ELN software systems such as Benchling.
Excellent interpersonal and collaborative skills, and the ability to work independently and effectively in a highly dynamic environment.
Comfortable communicating highly technical information.
Strong organizational and time management skills.
Proactive, creative, and positive attitude.

Nice To Haves

Experience with oligonucleotides or lipid nanoparticles.
Experience working on potency related testing.
Experience working on automation platforms.
Experience working with various biophysical instrumentation such as DLS, osmometer, pH, and basic fluorescence-based assays.
Ability to present data in team meetings.
Knowledge/hands-on experience in analytical method development, qualification, validation, and transfer to GMP environments.
Authorization to work in the United States indefinitely without restriction or sponsorship.

Responsibilities

Support and execute on activities to develop and qualify phase appropriate methods from the analytical research team intended for a variety of purposes, including release and stability testing, product characterization, high-throughput analysis, and characterization of complex raw materials.
Perform routine (approximately 60% effort) and non-routine (approximately 40% effort) potency assays.
Execution of techniques including sterile tissue culture, maintenance of mammalian cell culture preps, LNP handling, and cell-based or other LNP potency assays.
Potential for execution of DNA/RNA extraction from cells, PCR/NGS library preparation, real time PCR, reverse transcription or other techniques as needed.
Collect, process, and analyze experimental data, ensuring accurate and timely documentation in electronic notebook.
Review, interpret, and present data within the analytical team and cross-functionally.
Author, review, and revise technical source documents to support phase-appropriate analytical development needs.
Maintain laboratory equipment and order critical reagents.
Provide technical oversight to guide analytical/QC investigations, as needed.
Actively collaborate with internal and external process development and quality teams.
Other duties as assigned.