Full-Time

Senior Quality Control Analyst

Posted on 5/2/2024

Cellares

Cellares

51-200 employees

Automated cell therapy manufacturing platform

Data & Analytics
Hardware

Senior

Bridgewater Township, NJ, USA

Required Skills
Communications
Requirements
  • Bachelor's degree in a science discipline
  • 5+ 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)
  • 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
Responsibilities
  • Conduct routine and non-routine analytical, biochemical, and/or biological analysis
  • Work with cell therapy products and associated assays
  • 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
  • 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

Cellares specializes in advanced cell therapy manufacturing with its proprietary Cell Shuttle platform. This platform exemplifies industry leadership by integrating state-of-the-art automation and software solutions, significantly reducing process failure rates and costs. Working at this company provides the unique opportunity to contribute to life-saving innovations while being part of a culturally rich environment that collaborates with top-tier academic and industry partners worldwide.

Company Stage

Series C

Total Funding

$373M

Headquarters

South San Francisco, California

Founded

2019

Growth & Insights
Headcount

6 month growth

19%

1 year growth

46%

2 year growth

95%