Analytical Chemist

Job Description
Position SummaryApocus 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.
Primary ResponsibilitiesLaboratory 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. Analytical InstrumentationOperate 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 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 Method ValidationExecute analytical method validation protocols. Verify USP compendial methods. Support analytical method transfers. Troubleshoot chromatographic methods. Prepare validation reports. Equipment QualificationSupport and maintain: IQ OQ PQ Calibration Preventive maintenance Instrument performance qualification DocumentationPrepare and maintain: SOPs Test methods Laboratory notebooks Equipment logs Calibration records Validation documentation Certificates of Analysis OOS investigations CAPA documentation Regulatory ComplianceEnsure compliance with: FDA cGMP 21 CFR Parts 210 & 211 USP ALCOA+ Data Integrity Internal Quality Systems Required QualificationsEducationBachelor’s or Master’s Degree in: Chemistry Analytical Chemistry Pharmaceutical Sciences Biochemistry Related scientific discipline ExperienceRequired:5–10 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 Preferred:503B Outsourcing Facility Sterile manufacturing Waters Empower Chromeleon LIMS Stability testing Key SkillsThe 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 Pay: $57,000.00 – $70,000.00 per year

Benefits:
401(k) Dental insurance Health insurance Life insurance Vision insurance

Experience:
Working with HPLC and Lab: 5 years (Required) Ability to Relocate:San Antonio, TX 78213: Relocate before starting work (Required) Work

Location:
In person #J-18808-Ljbffr Imigrus