Analytical Chemist

Imigrus; San Antonio (TX); On-site; USD 57,000 - 70,000; Full time

Benefits offered by this job

401(k)

Dental insurance

Health insurance

Life insurance

Vision insurance

Job summary

Apocus seeks a Senior Analytical Chemist to independently operate and manage the analytical laboratory supporting our FDA-registered 503B outsourcing facility in San Antonio, TX. The role emphasizes HPLC operation, method validation, instrument qualification, and strict compliance with FDA cGMP and USP standards.

Required: 5–10 years in pharmaceutical analytics, strong HPLC troubleshooting, and ability to work with minimal supervision; in-person work with relocation to San Antonio.

Qualifications

• Education: Bachelor’s or Master’s in Chemistry or analytical sciences.
• Experience: 5–10 years in pharmaceutical analytical labs with GMP.
• Experience: Strong HPLC operation and troubleshooting.
• Experience: Method validation and instrument qualification.
• FDA inspection readiness is preferred.

Responsibilities

• Operate and independently manage analytical laboratory instruments.
• Schedule and perform daily laboratory testing.
• Maintain equipment and supplies; troubleshoot and calibrate.
• Perform method validation and support method transfers.
• Ensure compliance with FDA cGMP and USP standards.

Skills

HPLC operation

Troubleshooting

Method validation

GMP laboratories

Data review

Education

Bachelor’s in Chemistry

Analytical Chemistry

Tools

Waters Empower

Chromeleon

LIMS

HPLC systems

Job description

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