About this role
The position will support an Analytical Development client team that is responsible for ensuring the consistency, safety, and efficacy of biologics, including cutting-edge cell and gene therapies. The successful candidate will work in close partnership with bioprocessing, formulation, and data science groups to support manufacturing and quality control activities across the client’s development pipeline.
We are seeking a skilled analytical development scientist to work on the iPSC induced islet cell therapy program in the Analytical Development Bioassay Team. The position involves developing and executing bioanalytical assays for process development, in-process testing, and lot release. Knowledge and expertise in mammalian cell culture and flow cytometry are a must. The successful candidate must be self-motivated and able to support routine testing and assist with assay development.
Job Responsibilities and Requirements
Design and execute bioanalytical assays including flow cytometry, cell counting, dPCR/qPCR, ELISA, and cell-based bioassays.Perform routine sample testing for in-process testing and lot release.Optimize assay parameters (specificity, sensitivity, precision, accuracy, linearity, etc.).Support assay qualification and lifecycle management.Document experiments and protocols using electronic lab notebooks (e.g., Benchling).Troubleshoot assay and instrument issues.Collaborate cross-functionally with Process Development, R&D, and Quality teams.Author technical documentation: protocols, test methods, reports, SOPs. Basic Minimum Qualifications:
BS in Biology or related filed with at least 3 years of experience in drug development labs OR M.S. in Biology or related field with at least 1 year of experience in drug development labs. Hands-on experience with bioanalytical methods including flow-cytometry (multi-color flow cytometry with a minimum of 4-6 colors is preferred).Proficiency in mammalian cell culture techniques.Ability to troubleshoot and interpret experimental results and effectively present conclusions.Preferred Qualifications:
Hands-on experience with dPCR/qPCR and cell-based bioassays, such as glucose-stimulated insulin release, ELISA, and live cell plate assays.Experience improving assay throughput by utilizing multi-color flow cytometry and incorporating automated liquid handlers (e.g. Hamilton) and plate-based sample preparations.Experience with iPSC differentiation and handling iPSC-derived cells.Proficiency in method development and method qualification.Proficiency with data analysis tools (e.g., GraphPad Prism, FlowJo) and digital platforms (e.g., Benchling, SharePoint, Veeva).Strong troubleshooting and continuous improvement mindset.Knowledge of regulatory standards and ICH guidelines.Strong time management and organizational skills, with the ability to handle multiple priorities under tight deadlines.Excellent communication skills and the ability to work independently and collaborate in a team-oriented, matrixed environment.Willingness to take on additional responsibilities as needed, including occasional weekend work. Position is Full Time, Monday-Friday, 8am-5pm. Candidates currently living within a commutable distance of Boston, MA are encouraged to apply.
Excellent full-time benefits include:
Comprehensive medical coverage, dental, and vision optionsLife and disability insurance401(k) with company matchPaid vacation and holidaysEligibility for yearly goal-based bonus & merit-based increasesCompensation: $35.00-$41.00 per hour based on education and related experienceEurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.