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Position Summary\u00a0Apocus is seeking an experienced Senior Analytical Chemist to independently operate and manage the analytical laboratory supporting our FDA-registered 503B Outsourcing Facility. The successful candidate will be responsible for operating, troubleshooting, maintaining, qualifying, and optimizing analytical laboratory instrumentation, including HPLC systems, while performing analytical testing of raw materials, in-process samples, finished products, and stability samples in compliance with FDA cGMP regulations, USP standards, and internal quality procedures. This position requires an experienced pharmaceutical analytical chemist capable of working independently with minimal supervision. Will sponsor H1-B for right candidate.\u00a0Primary Responsibilities\u00a0Laboratory OperationsIndependently operate all analytical laboratory instruments.
Schedule and perform daily laboratory testing.
Maintain laboratory equipment and supplies.
Troubleshoot analytical instruments.
Coordinate preventive maintenance and calibration.
Maintain laboratory readiness for GMP operations.<\/p>\n
Analytical Instrumentation\u00a0Operate and maintain:HPLC \/ UHPLC
FTIR
UV-Visible Spectrophotometer
Analytical balances
Karl Fischer Titrator
pH meters
Conductivity meters
Osmometer
TOC Analyzer
Refrigerators and freezers
Stability chambers
General laboratory equipment<\/p>\n
Analytical TestingPerform testing for:
API identification
Potency (Assay)
Raw material release
Finished product release
Stability studies
Related substances \/ impurities
System suitability
Sample preparation
Data review<\/p>\n
Method ValidationExecute analytical method validation protocols.
Verify USP compendial methods.
Support analytical method transfers.
Troubleshoot chromatographic methods.
Prepare validation reports.<\/p>\n
Equipment QualificationSupport and maintain:
IQ
OQ
PQ
Calibration
Preventive maintenance
Instrument performance qualification<\/p>\n
DocumentationPrepare and maintain:
SOPs
Test methods
Laboratory notebooks
Equipment logs
Calibration records
Validation documentation
Certificates of Analysis
OOS investigations
CAPA documentation<\/p>\n
Regulatory ComplianceEnsure compliance with:
FDA cGMP
21 CFR Parts 210 & 211
USP
ALCOA+ Data Integrity
Internal Quality Systems<\/p>\n
Required Qualifications\u00a0EducationBachelor’s or Master’s Degree in:
Chemistry
Analytical Chemistry
Pharmaceutical Sciences
Biochemistry
Related scientific discipline<\/p>\n
Experience\u00a0Required:5\u201310 years of pharmaceutical analytical laboratory experience
Strong HPLC operation and troubleshooting experience
Experience with sterile injectable products preferred
Experience working in GMP laboratories
Analytical method validation
Equipment qualification
FDA inspection readiness
Experience operating multiple analytical instruments independently<\/p>\n
Preferred:503B Outsourcing Facility
Sterile manufacturing
Waters Empower
Chromeleon
LIMS
Stability testing<\/p>\n
Key Skills\u00a0The ideal candidate should be able to independently:Run HPLC analyses
Interpret chromatograms
Troubleshoot instruments
Qualify laboratory equipment
Validate analytical methods
Investigate OOS results
Prepare GMP documentation
Support FDA inspections
Train future laboratory staff<\/p>\n
Pay: $57,000.00 – $70,000.00 per year Benefits:401(k)
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Experience:Working with HPLC and Lab: 5 years (Required)<\/p>\n
Ability to Relocate:San Antonio, TX 78213: Relocate before starting work (Required)<\/p>\n
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