MiNK Therapeutics · 4 days ago
QC Scientist – Flow Cytometry (Cell Therapy)
Lexington, MA
Full-time
Onsite
Mid, Senior Level
$95K/yr - $130K/yr
4+ years expMiNK Therapeutics is a company focused on cell therapy products, and they are seeking a Quality Control Scientist to oversee analytical, microbiological, and environmental testing. The role involves ensuring the safety and quality of cell therapy products while serving as a technical resource for analytical methods and supporting GMP compliance and continuous improvement initiatives.
BiopharmaBiotechnologyManufacturingTherapeutics
Hiring Manager
Jeniece Waite
Responsibilities
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
Qualification
Required
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 GMP documentation, investigations, and change controls
Ability to train and qualify analysts in technical procedures and GMP compliance
Proactive, self-motivated team player who is comfortable working in a dynamic, fast-paced manufacturing setting, working independently with minimal supervision and adapting to changing schedules
Company
MiNK Therapeutics
MiNK Therapeutics is a biopharmaceutical company developing allogeneic iNKT cell therapies and immune technologies for treatment.
11-50 employees
H1B Sponsorship
MiNK Therapeutics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
Funding
Current Stage
Public CompanyTotal Funding
$5.8MKey Investors
National Institute of Allergy and Infectious DiseasesGKCC
2025-06-02Grant
2024-05-13Post Ipo Equity· $5.8M
2021-10-14IPO
Leadership Team
Jennifer Buell
President and Chief Executive Officer
Recent News
2025-11-21
Company data provided by crunchbase