Full-Time

Quality Control Analyst

Microbiology

Posted on 5/2/2024

Cellares

Cellares

51-200 employees

Integrated platform for cell therapy manufacturing

Data & Analytics
Hardware

Mid

Bridgewater Township, NJ, USA

Requirements
  • BA or B.S. degree in a science discipline
  • 2+ years of experience in cGMP or cGxP at an operational level supporting manufacturing in a pharmaceutical or biotech environment
  • Prior experience with Environmental Monitoring and microbiological assays
  • Knowledge of pharmaceutical cGMP (US and EU)
  • Must be able to commute to Bridgewater, New Jersey
  • Excellent verbal, written, interpersonal, organizational, and communication skills
  • Self-awareness, integrity, authenticity, and a growth mindset
Responsibilities
  • Conduct Environmental Monitoring of isolators and ISO 8 cleanrooms
  • Conduct Utilities Monitoring of compressed gas systems
  • Conduct routine and non-routine microbiological testing of materials and cell therapy products
  • Prepare COA/COT for testing performed
  • Support method qualification and transfer
  • Write and revise Quality Control SOPs, protocols, and reports
  • Perform timely and accurate peer review of test results/reports
  • Identify discrepancies, initiate and investigate OOS/OOT results
  • 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 of microbiological methods
  • Maintain required training and training records and provide training to qualify other associates
  • Participate in internal assessments and audits
  • Support equipment validation, calibration, maintenance, and troubleshooting
  • 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 laboratory and maintain a clean work environment
  • Perform other duties as assigned

Cellares offers the Cell Shuttle, an integrated platform for cell therapy manufacturing, utilizing Industry 4.0 technologies to enable true walk-away, end-to-end automation, modular hardware, purpose-built process design software, and scalable manufacturing from preclinical to commercial scale, resulting in reduced process failure rates and up to 70% cost reduction compared to manual processes. The company aims to accelerate access to life-saving cell therapies by deploying Cell Shuttles in Smart Factories globally, partnering with academia, biotechs, and pharma companies to lower manufacturing costs and meet global patient demand.

Company Stage

Series C

Total Funding

$373M

Headquarters

South San Francisco, California

Founded

2019

Growth & Insights
Headcount

6 month growth

16%

1 year growth

47%

2 year growth

96%