Full-Time
Senior Quality Control Analyst
Microbiology
Confirmed live in the last 24 hours
Cellares
51-200 employees
Develops and manufactures cell therapies efficiently
Compensation Overview
$90k - $210kAnnually
Senior
Bridgewater Township, NJ, USA
- BA or B.S. degree in a science discipline required, or comparable experience
- 5+ years of experience in cGMP or cGxP at an operational level supporting manufacturing in a pharmaceutical or biotech environment, is preferred
- Prior experience with Environmental Monitoring and microbiological assays (endotoxin, mycoplasma, sterility)
- 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
- Excellent verbal, written, organizational, presentation and interpersonal skills
- Self-awareness, integrity, authenticity, and a growth mindset
- Conduct Environmental Monitoring of isolators and ISO 8 cleanrooms (non-viable and viable air particulate, surface viables) in a GMP manufacturing facility
- Conduct Utilities Monitoring of compressed gas systems (non-viable and viable air particulate, dewpoint, hydrocarbons) in a GMP manufacturing facility
- Conduct routine and non-routine microbiological testing of materials and cell therapy products (Gram stain, growth promotion, endotoxin, mycoplasma, sterility)
- 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 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 of microbiological methods commensurate with experience
- 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
- 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 develops and manufactures cell therapies in the biotechnology sector, operating as an Integrated Development and Manufacturing Organization (IDMO) that combines these processes in one facility. Its proprietary "Smart Factory" technology features an automated single-use cartridge system, which increases productivity, reduces costs, and lowers process failure rates compared to traditional methods. The company serves a range of clients, including preclinical, clinical, and commercial entities, and has partnerships with major pharmaceutical companies for CAR-T cell therapy manufacturing. Cellares aims to provide efficient and cost-effective manufacturing services, distinguishing itself from competitors in the biotechnology industry.
Company Stage
Series C
Total Funding
$373M
Headquarters
South San Francisco, California
Founded
2019
6 month growth
↑ 20%1 year growth
↑ 35%2 year growth
↑ 95%
Simplify's Take
What believers are saying
- The $380M worldwide capacity reservation and supply agreement with Bristol Myers Squibb underscores Cellares' strong market position and growth potential.
- The launch of Cell Q, the world's first automated cGMP QC workcell, demonstrates Cellares' commitment to innovation and operational efficiency.
- The addition of industry veteran Christi Shaw to the advisory board brings invaluable expertise and leadership to the company.
What critics are saying
- The complexity of integrating advanced technologies like the Cell Shuttle and Cell Q could lead to operational challenges and delays.
- The highly competitive biotechnology sector requires continuous innovation to maintain a leading position, which can be resource-intensive.
What makes Cellares unique
- Cellares is the first Integrated Development and Manufacturing Organization (IDMO), combining development and manufacturing processes under one roof, unlike traditional CDMOs.
- Their proprietary 'Smart Factory' technology, including automated single-use cartridge systems, significantly boosts productivity and reduces costs and process failure rates.
- Strategic partnerships with major pharmaceutical companies like Bristol Myers Squibb and Lyell highlight their industry credibility and advanced capabilities.