Position Summary Apocus 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 Responsibilities Laboratory Operations Independently 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 Instrumentation Operate 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 Testing Perform testing for: API identification Potency (Assay) Raw material release Finished product release Stability studies Related substances / impurities System suitability Sample preparation Data review Method Validation Execute analytical method validation protocols. Verify USP compendial methods. Support analytical method transfers. Troubleshoot chromatographic methods. Prepare validation reports.

Equipment Qualification Support and maintain:

IQ OQ PQ

Calibration Preventive maintenance Instrument performance qualification Documentation Prepare and maintain: SOPs Test methods Laboratory notebooks Equipment logs Calibration records Validation documentation Certificates of Analysis OOS investigations CAPA documentation Regulatory Compliance Ensure compliance with: FDA c

GMP 21 CFR

Parts 210 & 211 USP ALCOA+ Data Integrity Internal Quality Systems Required Qualifications Education Bachelor's or Master's Degree in: Chemistry Analytical Chemistry Pharmaceutical Sciences Biochemistry Related scientific discipline

Experience Required:

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 Skills The 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