Job Title: Analytical Chemist – HPLC, & Process Validation Experience
Job Type: Full-Time | On-Site
Industry: Pharmaceutical Manufacturing / Compounding / 503B Outsourcing

POSITION SUMMARY:

We are seeking a detail-oriented and experienced Analytical Chemist with a strong background in HPLC chromatography and method validation. The successful candidate will play a key role in developing, validating, and executing analytical methods to ensure the identity, strength, quality, and purity of compounded medications.

QUALIFICATIONS:

• Bachelor’s or Master’s degree in Chemistry, Pharmaceutical Sciences, or a related field
• Minimum 2 years of hands-on experience with HPLC analysis in a pharmaceutical or regulated environment
• Strong knowledge of method validation parameters: accuracy, precision, linearity, specificity, robustness, LOD/LOQ
• Familiarity with USP, ICH Q2(R1), and cGMP guidelines
• Excellent documentation and communication skills
• Ability to manage multiple projects and meet tight deadlines

PREFERRED EXPERIENCE (NOT REQUIRED):

• Experience in a sterile compounding facility or 503B outsourcing pharmacy
• Use of other analytical instruments (e.g., HPLC, UV-Vis, GC, FTIR)
• Empower or ChemStation software experience

• Operate and maintain HPLC systems (preferably Agilent or equivalent) for routine and non-routine analysis
• Develop and validate analytical methods in compliance with USP, ICH, and FDA guidelines
• Perform assay, impurity, stability, and release testing for raw materials and finished products
• Document all analytical activities in accordance with GMP and internal SOPs
• Investigate and troubleshoot analytical and instrumentation issues
• Collaborate with QA/QC and R&D teams to support product development and regulatory submissions
• Prepare analytical reports, protocols, and validation summaries