Senior Quality Control Analyst - Cellares
View Company Profile- Job Title
- Senior Quality Control Analyst
- Job Location
- Bridgewater, NJ
- Job Description
- We are seeking an innovative, creative, and detail-oriented Senior 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. The level will be determined based upon the candidate’s education, skills, and/or related experience.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.
- 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
- 5+ 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
- Excellent verbal, written, organizational, presentation and interpersonal skills
- Self-awareness, integrity, authenticity, and a growth mindset
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Cellares Company Size
Between 100 - 500 employees
Cellares Founded Year
2019
Cellares Total Amount Raised
$355,000,000
Cellares Funding Rounds
View funding detailsSeries C
$255,000,000 USD
Series B
$82,000,000 USD
Series A
$18,000,000 USD