MiNK Therapeutics · 1 week ago
Contract-Quality Control Analyst
Lexington, MA
Contract
Onsite
Entry, Mid Level
$60K/yr - $89K/yr
2+ years expMiNK Therapeutics is a company focused on cell therapy products, and they are seeking a Quality Control Analyst to support their Quality organization. The role involves performing analytical, microbiological, and environmental testing to ensure safety and quality, as well as maintaining compliance with GMP requirements and SOPs.
BiopharmaBiotechnologyManufacturingTherapeutics
Hiring Manager
Jeniece Waite
Responsibilities
Perform analytical and microbiological testing in support of development, donor screening, in-process control, product release, and raw-material release following SOPs and GMP requirements
Conduct environmental and personnel monitoring of controlled areas, including viable air, non-viable particulates, surface, and gowning monitoring
Perform environmental data entry, verification, and trend analysis to monitor cleanroom performance and identify potential contamination trends
Execute microbiological assays such as sterility, endotoxin (LAL), bioburden, growth-promotion, gram staining and conductivity/TOC testing
Perform analytical assays including but not limited to cell counts and flow-cytometry-based identity or purity testing
Responsible for sample management, including receipt, labeling, storage, tracking, and distribution, in compliance with GMP requirements and established laboratory procedures
Compile and verify test results to support generation of Certificates of Analysis (CoA) for in-process materials, intermediates, and drug product release
Participate in aseptic process simulation (media-fill) run; provide on-floor QC support during execution and perform subsequent media incubation, inspection, and documentation
Sample, test, and document raw-material results to support disposition
Coordinate external testing activities by preparing and shipping samples to qualified contract laboratories, tracking results and maintaining documentation
Prepare reagents, media, and solutions as needed; maintain inventory of consumables and ensure proper labeling and traceability
Support instrument calibration, maintenance, and qualification activities
Assist with deviation investigations, change controls, and CAPA implementation under direction of QC leadership
Contribute to the revision of SOPs and test methods to ensure clarity and compliance
Maintain cleanroom gowning qualification and aseptic technique proficiency
Ensure completeness, accuracy, and traceability of all test data included in CoA packages prior to QA review
Work a flexible schedule to support manufacturing operations, including occasional weekends, holidays, extended hours, or off-shift coverage as required
Qualification
Required
Minimum 2-4 years relevant QC experience in a GMP-regulated and clean room environment
Demonstrated proficiency in analytical and microbiological testing, including flow cytometry, cell counting, endotoxin, sterility, and environmental monitoring
Requires Bachelor's degree in a scientific discipline or equivalent combination of education and experience
Hands-on experience in a GMP-regulated or cleanroom laboratory environment
Familiarity with aseptic technique and contamination-control principles
Experience performing environmental monitoring (viable air, surface, personnel, and non-viable particulates)
Knowledge of microbiological methods including endotoxin (LAL), sterility, bioburden, gram staining and growth-promotion testing
Basic proficiency in flow cytometry, including sample handling, staining, and data acquisition
Experience performing cell counts and viability testing using automated or manual methods
Working knowledge of GMP documentation and data integrity requirement and standards
Familiarity with equipment calibration, qualification, and maintenance
Competence with data entry and verification in tracking systems (paper or electronic)
Understands raw material sampling and testing processes
Ability to perform basic data trending and report generation for EM or analytical results
Team player that is comfortable working in a fast-paced, schedule-driven environment to support manufacturing operations
Preferred
Experience supporting or coordinating external laboratory testing
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