Kelly Science, Engineering, Technology & Telecom
Senior Chemist
Kelly Science, Engineering, Technology & Telecom, Princeton, New Jersey, us, 08543
Scientific Recruiter @ Kelly Science | Staffing, Biotech, Pharma, Clinical
The role offers full benefits, 401K transfer/rollover, PTO, and paid holidays.
Key Responsibilities
Perform QC analytical testing for drug substances (DS), drug products (DP), and stability samples to support product release and manufacturing timelines.
Conduct routine lab operations including instrument calibration, qualification, maintenance, and reagent/supply inventory management.
Generate and revise SOPs, testing specifications in compliance with cGMP guidelines. Execute and support laboratory investigations such as OOS, OOT, deviations, and invalid assay results.
Implement and monitor CAPAs following root cause analysis.
Participate in method transfer and validation activities, including protocol development, execution, and reporting.
Technical Skills & Experience
Bachelor’s degree or higher in Chemistry, Biochemistry, Biotechnology, or a related scientific field.
Minimum of 2 years of QC experience in a GMP-regulated pharmaceutical or biotechnology setting.
Proficient in analytical methods for biologics, including but not limited to:
HPLC/UPLC, Gas Chromatography (GC), Total Organic Carbon (TOC)
UV-Vis Spectrophotometry, Sub-visible Particulate Testing
Container Closure Integrity Testing (CCIT), N-glycan profiling
Strong understanding of USP/EP, FDA, cGMP, and EU GMP regulations.
Familiarity with equipment validation and qualification processes.
Job Details
Seniority level:
Mid-Senior level
Employment type:
Full-time
Job function:
Science, Manufacturing, and Research
Industries:
Pharmaceutical Manufacturing, Biotechnology Research, and Chemical Raw Materials Manufacturing
Benefits
Medical insurance
Vision insurance
401(k)
Disability insurance
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Key Responsibilities
Perform QC analytical testing for drug substances (DS), drug products (DP), and stability samples to support product release and manufacturing timelines.
Conduct routine lab operations including instrument calibration, qualification, maintenance, and reagent/supply inventory management.
Generate and revise SOPs, testing specifications in compliance with cGMP guidelines. Execute and support laboratory investigations such as OOS, OOT, deviations, and invalid assay results.
Implement and monitor CAPAs following root cause analysis.
Participate in method transfer and validation activities, including protocol development, execution, and reporting.
Technical Skills & Experience
Bachelor’s degree or higher in Chemistry, Biochemistry, Biotechnology, or a related scientific field.
Minimum of 2 years of QC experience in a GMP-regulated pharmaceutical or biotechnology setting.
Proficient in analytical methods for biologics, including but not limited to:
HPLC/UPLC, Gas Chromatography (GC), Total Organic Carbon (TOC)
UV-Vis Spectrophotometry, Sub-visible Particulate Testing
Container Closure Integrity Testing (CCIT), N-glycan profiling
Strong understanding of USP/EP, FDA, cGMP, and EU GMP regulations.
Familiarity with equipment validation and qualification processes.
Job Details
Seniority level:
Mid-Senior level
Employment type:
Full-time
Job function:
Science, Manufacturing, and Research
Industries:
Pharmaceutical Manufacturing, Biotechnology Research, and Chemical Raw Materials Manufacturing
Benefits
Medical insurance
Vision insurance
401(k)
Disability insurance
#J-18808-Ljbffr