Job description
Join CatalystChem Research Inc., a leading innovator in analytical chemistry for pharmaceuticals and advanced materials. We are seeking a Senior Analytical Chemist to spearhead method development, validation, and high-quality data generation in a GMP/GxP environment. You will collaborate with cross-functional teams to deliver robust, compliant analytical solutions that accelerate product development.
In this role, you will contribute to all phases of analytical work, from design of experiments to transfer to manufacturing, ensuring accuracy, precision, and full traceability of results. The ideal candidate combines deep technical expertise with clear communication and a collaborative mindset.
What you'll do includes instrument optimization, method transfer, and cross-department collaboration to deliver validated methods that meet regulatory standards.
Responsibility
- Lead development, validation, and transfer of analytical methods (HPLC/UHPLC, GC/LC-MS, NMR) in GMP/GxP environments.
- Design and execute method validation protocols (LOQ/LOD, linearity, precision, accuracy) and ensure quality data generation.
- Maintain data integrity and compliance with 21 CFR Part 11, GLP, and ISO 17025 in all activities.
- Collaborate with R&D, QA, and Manufacturing to optimize workflows and support tech transfer to production.
- Mentor and train junior analysts, oversee instrument maintenance, calibration, and preventive upkeep.
- Prepare technical reports, SOPs, and method transfer packages; present findings to cross-functional teams.
- Manage laboratory operations, safety programs, and inventory control for analytical instruments and consumables.
Qualification
- Master's degree in Analytical Chemistry, Chemistry, or a closely related field; PhD preferred; 5+ years of relevant experience accepted.
- Strong expertise in HPLC/UHPLC and GC/GC-MS, plus LC-MS; NMR experience is a plus.
- Proven track record with GMP/GxP, GLP, ISO 17025, and data integrity requirements.
- Proficiency with analytical software (LIMS, Empower, MassLynx, ChemStation) and statistical analysis.
- Excellent problem-solving, communication, and mentoring skills; ability to work cross-functionally in fast-paced settings.
- Authorization to work in the United States without sponsorship.