Analytical Chemist

We are seeking a skilled Analytical Chemist to support late-stage development and lifecycle management within our Global Technical Operations team. In this dynamic role, you will leverage your expertise in analytical method development, validation, and transfer to both internal and external GMP laboratories. You will play a critical role in the isolation and characterization of trace-level impurities in drug substances and drug products, ensuring the highest standards of data quality and regulatory compliance.

This position offers the opportunity to collaborate in a cross-functional environment, working closely with teams in Process Chemistry, Formulation, Quality, Operations, and Regulatory to drive the successful execution of key deliverables.

• BA or BS in Analytical Chemistry or related science typically with a minimum of 5 years of pharmaceutical/biotech or related work experience in industry.

• MS in Analytical Chemistry or related science typically with a minimum of 2 years of pharmaceutical/biotech or related work experience in industry.

• PhD in Analytical Chemistry or related science

• Extensive hands-on experience with HPLC/UPLC, LC-MS, GC, GC-MS, TGA, DSC, UV, and IR spectroscopy for drug characterization and quantitation.

• Expertise in method development, validation, and transfer for small molecules, peptides, and biologics.

• Strong analytical chemistry problem-solving skills, including trace-level impurity characterization in drug substances and products.

• Experience with extractable and leachable analysis, biocompatibility testing, and chemical characterization.

• Knowledge of regulatory standards, including ISO 10993, ISO 18562, EU MDR (GSPR), ICH guidelines, and pharmacopeial requirements.

• Familiarity with QbD method development tools and regulatory compliance.

• Self-starter with a strong work ethic, communication, and project management skills.

• Ability to work independently and collaboratively in a cross-functional team environment.

• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Project, Visio) and Adobe.

• Strong organizational, planning, and interpersonal skills.

Preferred Skills

• Strong familiarity with pharmaceutical GMP and regulatory guidelines

• Practical experience in bioanalytical chemistry

• Experience with administration and/or support of Waters Empower

• Experience with Agilent and Waters analytical instruments and associated software

Position directly reports to the Sr. Manager, Analytical Chemistry.

This position requires frequent work in a research laboratory, both standing at a bench and seated. It also requires reaching into flammable cabinets. This position involves frequent work in an office environment, using a computer to analyze data and write reports and documenting experiments in notebooks. Occasional travel may be required for engagement with external laboratories and collaborators.

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