Associate Research Scientist - Bioassay

## Role Summary: Perform biological assays and GMP sample testing to support drug development and commercial projects, with a primary focus on routine GMP sample testing support, cell banking activities, and execution of all associated project and sample-testing tasks. The role reliably conducts complex sample preparation and analysis following validated and experimental procedures with limited supervision, maintains data integrity in accordance with SOPs, protocols, and product specifications, and works collaboratively with project teams to support method execution, troubleshooting, and continuous improvement of bioassay workflows. ## Key responsibilities: - Performing routine GMP sample testing for cell-based potency and other biological assays in support of development and commercial products, following approved methods and SOPs. - Executing sample receipt and testing activities in compliance with GMP and internal quality systems. - Maintaining and expanding mammalian cell lines, including routine cell culture, characterization, and generation of project-specific cell banks for bioassay use. - Supporting qualification, validation, and transfer of bioassays into GMP laboratories and/or external testing sites. - Applying aseptic techniques and standardized laboratory procedures to minimize contamination risk and ensure assay robustness and reproducibility. - Documenting all experimental activities in electronic and/or paper laboratory notebooks; performing self-review of data and preparing data packages for QC review and reporting. - Assisting in troubleshooting assay performance issues and implementing corrective and preventive actions, escalating issues appropriately. - Collaborating with project scientists, to ensure on-time delivery of sample testing and clear communication of results and issues. - Adhering to all safety, data integrity (ALCOA+), and compliance requirements within Client policies and procedures, and supporting continuous improvement of laboratory ways of working. ## Education and Experience: - PhD within Chemistry ( Organic/ Synthetic Chemistry) and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable 2+ years’) - OR Masters degree and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable 4+ years’) - OR BS degree and Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable 6+years’) - Demonstrated experience with mammalian cell culture, cell banking, and aseptic techniques. - Prior experience performing GMP sample testing, preferably in cell-based potency bioassays or related biological assays. - Experience designing, troubleshooting, and executing bioassay experiments with some supervision. - Proven ability to analyze data, interpret results, and report findings in laboratory notebooks and standardized report formats. - Experience performing and analyzing cell-based potency bioassays in a pharmaceutical/biotechnology or academic environment. - Hands-on experience culturing immortalized adherent and suspension cell lines; familiarity with generation and characterization of research or GMP cell banks. - Working knowledge of GMP principles, data integrity requirements, and laboratory quality systems. - Experience using laboratory automation and electronic data systems (e.g., ELN, LIMS) is a plus. - Prior experience in an academic institution, biotechnology or pharmaceutical industry, preferably in a regulated (GMP/GLP) setting.