USA - Analytical Chemist - III - USD

Key Responsibilities

• Perform laboratory testing of: Raw materials, Drug substances, Drug products, In-process samples, Stability samples
• Conduct routine wet chemistry and analytical testing using laboratory instrumentation, including: HPLC, GC, UV-Visible Spectroscopy, CGE, ICE, Polarimeter, Osmometer, pH Meter, Conductivity Meter, TOC Analyzer
• Accurately document and review analytical results using electronic laboratory systems (LIMS)
• Follow all cGMP requirements, laboratory procedures, SOPs, and regulatory guidelines
• Participate in peer review of data and laboratory documentation
• Maintain laboratory equipment and ensure testing is performed according to approved methods
• Support internal and external audits by maintaining thorough and compliant documentation
• Complete required training in laboratory operations, safety procedures, and quality systems

Required Qualifications

• Bachelor's or master's degree in: Chemistry/Biochemistry/Pharmaceutical Sciences or Related scientific discipline
• Minimum 5 years of experience in a GMP/cGMP Quality Control laboratory environment
• Experience within the pharmaceutical or biopharmaceutical industry is required
• Hands-on experience with analytical instrumentation such as HPLC, GC, and UV
• Strong understanding of GMP documentation practices and regulatory compliance
• Experience working with electronic laboratory systems and data management tools
• Ability to follow detailed procedures and maintain a high level of accuracy

Preferred Qualifications

• 5-7 years of pharmaceutical QC laboratory experience
• Experience using Empower chromatography software
• Previous involvement in audit-ready environments
• Experience reviewing laboratory documentation and SOPs

Safety Requirements

• This position supports testing activities involving high-potency oncology products
• Candidates must be comfortable working in a controlled laboratory environment that requires:
• Strict adherence to safety procedures
• Use of personal protective equipment (PPE)
• Use of respiratory protection when required
• Compliance with OSHA and site-specific safety requirements
• All necessary training and safety equipment will be provided