QC Scientist – Flow Cytometry (Cell Therapy)
14 hours ago
Lexington
The role: The Quality Control Scientist is responsible for execution and oversight of analytical, microbiological, and environmental testing to ensure the safety and quality of cell therapy products and manufacturing operations. The role includes performing GMP testing to support development, donor screening, in-process control, product release, stability, raw material release, and environmental monitoring in accordance with Standard Operating Procedures (SOPs). The QC Scientist serves as a technical resource for analytical methods such as flow cytometry and other cell-based assays, supports assay and equipment qualification, and ensures data integrity and regulatory compliance. Additional responsibilities include authoring or revising procedures, leading continuous improvement initiatives, supporting investigations, contributing to assay development efforts, and train staff as needed. In the role you will: • Perform analytical, microbiological, and environmental testing in support of development, donor-screening, in-process control, product release, stability, and raw-material release in accordance with SOPs and GMP requirements., • Serve as a technical lead for flow-cytometry–based analytical assays, including instrument setup, compensation, gating strategy, data analysis, and troubleshooting., • Perform and review cell count assays and evaluate data., • Support method qualification, validation, and transfer for flow cytometry, cell counting, and other analytical assays; ensure accurate, reproducible data generation., • Conduct environmental and personnel monitoring of controlled areas, including viable air, non-viable particulates, surface, and gowning monitoring., • Oversee environmental data entry, review, and trend analysis; evaluate results against alert and action levels and support investigations for excursions or adverse trends., • Execute and review microbiological assays such as sterility, endotoxin (LAL), bioburden, gram staining, growth-promotion, and conductivity/TOC testing., • Participate in aseptic process simulation (media-fill) runs; provide on-floor QC support during execution and perform subsequent media incubation, inspection, and documentation., • Sample, test, and document raw-material results and manage disposition., • Establish and manage relationships with qualified contract laboratories; oversee external testing activities, ensure timely data delivery, review results, and verify accuracy for inclusion in release documentation., • Compile, verify, and review analytical and microbiological data to support generation of Certificates of Analysis (CoA) for raw materials, intermediates, and drug-product release., • Oversight of stability testing for intermediates and product to support shelf-life claims and IND submission., • Author and revise SOPs, test methods, and data records; contribute to laboratory continuous-improvement initiatives., • Author and revise technical reports and support IND submissions., • Support and provide technical input to deviation, OOS, and CAPA investigations, ensuring scientific rationale and data integrity., • Participate in equipment calibration, qualification, and maintenance programs, and assist in implementation of new or revised analytical methods., • Train staff in flow cytometry, microbiological methods, and GMP documentation practices., • Maintain compliance with GMP, data-integrity, and safety requirements, ensuring laboratory readiness for internal and regulatory inspections., • Provide input to QC metrics and data-trending reports for management review., • Maintain a flexible schedule to accommodate manufacturing and testing demands, including periodic weekend, holiday, or extended-hour work and off-shift coverage as needed. Qualifications: About you • Minimum 4-6 years relevant QC experience in a GMP and cleanroom environment, supporting biologics or cell therapy products., • Demonstrated proficiency in analytical and microbiological testing, including flow cytometry, cell counting, endotoxin, sterility, and environmental monitoring., • Proven experience supporting method qualification, validation, and transfer activities., • Strong understanding of data review, good documentation practices, and data integrity., • Experience conducting and authoring investigations, CAPA development, and laboratory deviation documentation., • Experience collaborating cross-functionally with Manufacturing, QA, and Analytical Development teams to support GMP operations., • Requires Bachelor’s degree in a scientific discipline or equivalent combination of education and experience., • Expertise in flow cytometry, including instrument setup, compensation, gating, and data analysis., • Experience leading method qualification, transfer, and troubleshooting for analytical and microbiological assays., • Advanced understanding of aseptic technique and contamination control in GMP cleanroom operations., • Experience performing or reviewing microbiological assays, including endotoxin (LAL), sterility, bioburden, gram staining and growth-promotion testing., • Familiarity with environmental and personnel monitoring, including data trending and evaluation against alert/action levels., • Experience performing or reviewing in-process and release testing for cell-based products., • Strong knowledge of raw material testing programs, including identity, endotoxin, and bioburden verification., • Experience coordinating and reviewing external testing with qualified contract laboratories., • Proficiency in data review, trending, and reporting using paper or electronic based systems., • Strong understanding and ability for authoring f GMP documentation, investigations, and change controls., • Ability to train and qualify analysts in technical procedures and GMP compliance.
