Quality Control Analyst

Cellares

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Bridgewater, NJ on site Until 8/23/2026 H-1B sponsor history First posted June 2, 2025 Last posted December 13, 2025
Job description
We are seeking an innovative, creative, and detail-oriented Quality Control Analyst to join our team in Bridgewater, New Jersey. This position will be responsible for routine and non-routine QC testing according to Standard Operating Procedures (SOPs).  This role supports the day-to-day operations within the Quality Control group via execution of analytical testing. This includes but is not limited to in-process testing, lot release testing, stability testing, and raw material testing. All activities are all performed in accordance with cGMP guidelines and are supported by departmental and inter-departmental policies and standard operating procedures.
 
This role will be a hands-on resource reporting to the Senior Director, Quality Control Bioanalytics.  
 
Candidates should enjoy working in a fast-paced, mission-driven environment, and be prepared to tackle a broad selection of challenges as the company grows.

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

Requirements

  • Bachelor's degree in a science discipline required, or comparable experience
  • 2+ years of experience in cGMP or cGxP at an operational level supporting manufacturing in a pharmaceutical or biotech environment, is preferred
  • 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 is preferred
  • Knowledge of pharmaceutical cGMP (US and EU) is preferred
  • Must have excellent verbal, written, interpersonal, and organizational and communication skills
  • Must be able to commute to Bridgewater, New Jersey
  • Self-awareness, integrity, authenticity, and a growth mindset
This is Cellares

Cellares is the first Integrated Development and Manufacturing Organization (IDMO) and takes an Industry 4.0 approach to mass manufacturing the living drugs of the 21st century. The company is both developing and operating integrated technologies for cell therapy manufacturing to accelerate access to life-saving cell therapies. The company’s Cell Shuttle integrates all the technologies required for the entire manufacturing process in a flexible and high-throughput platform that delivers true walk-away, end-to-end automation. Cell Shuttles will be deployed in Cellares’ Smart Factories around the world to meet total patient demand for cell therapies at global scale. Partnering with Cellares enables academics, biotechs, and pharma companies to accelerate drug development and scale out manufacturing, lower process failure rates, lower manufacturing costs, and meet global patient demand.
The company is headquartered in South San Francisco, California with its commercial-scale IDMO Smart Factory in Bridgewater, New Jersey. The company is backed by world-class investors and has raised over $355 million in financing.

Leveling will be based on overall experience, education, and demonstration of knowledge throughout the interview process.

Compensation (from employer):
90000–210000 USD per year

About this role

Summary

Perform analytical testing and data review supporting manufacturing in cGMP biotech environment

Job title

Quality Control Analyst

Experience level

2+ years

Industry

pharmaceutical

Location requirements

Bridgewater, NJ; on-site required, no remote work

Salary

90000–210000 USD per year

Visa sponsorship

H-1B sponsor history

Management role

No

Skills & keywords

Required skills

spectrophotometryflow cytometryqPCRbioanalytical techniquesregulatory compliance

Preferred skills

cell-based potencymethod validationdeviation investigationvalidation protocolstraining and SOP writing

Specializations

biochemical analysiscell therapyassay developmentvalidationcGMP
Locations

Structured locations inferred from the posting.

Bridgewater, NJ, USA

On-site City
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