Cellares · 16 hours ago
Quality Control Analyst
Bridgewater, NJ
Full-time
Onsite
Entry, Mid Level
$90K/yr - $210K/yr
2+ years expCellares is the first Integrated Development and Manufacturing Organization (IDMO) focused on mass manufacturing cell therapies. The Quality Control Analyst will be responsible for routine and non-routine QC testing, supporting daily operations within the Quality Control group in accordance with cGMP guidelines.
BiotechnologyLife ScienceManufacturingMedicalTherapeutics
Responsibilities
Conduct routine and non-routine analytical, biochemical, and/or biological analysis such as, in-process materials, raw materials, finished goods, or stability samples
Work with cell therapy products and associated assays (dPCR, qPCR, cell-based potency assays, proliferation assays, ELISA, flow cytometry assays, etc.)
Perform timely and accurate peer review of analytical test results/reports
Prepare COA/COT for testing performed
Identify discrepancies, initiate and investigate OOS/OOT results for phase 1 and phase 2
Initiate and investigate deviations related to quality control
Compile and review data to ensure accuracy and regulatory compliance
Support development for specifications and justification of specifications
Participate in validation and technical transfer of analytical methods commensurate with experience
Write and revise test methods
Maintain required training and training records and provide training to qualify other associates
Participate in internal assessments and audits as required
Support equipment validation, calibration, maintenance, and troubleshooting
Write method validation protocol/reports and other documentation such as test reports
Write stability protocol and stability reports
Write and revise Quality Control Standard Operating Procedures
Supply Quality Control data necessary for regulatory submissions
Support Quality Systems such as; change control, deviation, CAPA, audits, quality metrics, etc
Assist in general upkeep of the laboratory and maintain a clean work environment
Perform other duties as assigned
Qualification
Required
Bachelor's degree in a science discipline required, or comparable experience
Must have excellent verbal, written, interpersonal, and organizational and communication skills
Must be able to commute to Bridgewater, New Jersey
Excellent verbal, written, organizational, presentation and interpersonal skills
Self-awareness, integrity, authenticity, and a growth mindset
Preferred
2+ years of experience in cGMP or cGxP at an operational level supporting manufacturing in a pharmaceutical or biotech environment
Prior experience related to method development/validation
Prior experience with immune cell phenotyping by multicolor flow cytometry, dPCR, qPCR, cell-based potency and other cell therapy related assays
Knowledge of pharmaceutical cGMP (US and EU)
Benefits
Highly subsidized Medical, Dental, and Vision Plans
401(k) Matching
Onsite lunches
Stock options
Company
Cellares
Cellares is a life sciences technology company that develops the Cell Shuttle to automate cell therapy manufacturing.
51-200 employees
H1B Sponsorship
Cellares 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 (1)
2024 (2)
2023 (2)
2022 (1)
2020 (1)
Funding
Current Stage
Growth StageTotal Funding
$355MKey Investors
Koch Disruptive TechnologiesEclipse Ventures
2023-08-23Series C· $255M
2021-05-05Series B· $82M
2020-10-29Series A· $18M
Leadership Team
Fabian Gerlinghaus
Co-Founder & CEO
Omar Kurdi
Co-Founder and President
Recent News
Genetic Engineering News
2026-01-16
Morningstar.com
2026-01-12
Company data provided by crunchbase