Analytical Chemist, R&D

Key Responsibilities

• Partner with qualified external testing laboratories to support commercialization efforts, ensuring accurate, reliable, and timely analytical testing results.
• Support and conduct the development, qualification and validation of analytical methods for active pharmaceutical ingredients (APIs), supplemental ingredients and peptides, ensuring compliance with regulatory requirements.
• Analyze data, interpret results, and document findings to support R&D development activities, process validation batches, equipment validations, formula optimizations, site and tech transfers.
• Develop, edit, and maintain clear, accurate technical documentation (SOPs, test methods, validation reports, and specifications) to support R&D and Operations functions.
• Ensure all analytical activities adhere to Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP), maintaining accurate and up-to-date documentation.
• Collaborate with R&D analytical, project management, R&D formulation, operations and quality teams to support product development and troubleshoot issues.
• Prepare documentation that supports the R&D testing strategy for new and existing products to minimize risk and ensure patient safety.
• Contribute to process improvements to enhance efficiency and data quality.

Qualifications

• Bachelor’s or Master’s degree in Chemistry, Pharmaceutical Sciences, or related field.
• Minimum of 5 years of experience in analytical chemistry, preferably in the pharmaceutical industry with a focus on method development and validation.
• Proficiency in analytical techniques such as HPLC, GC, IR, UV, MS, and dissolution testing.
• Experience with testing multi-analyte dosage forms such as tablets, chews, gummies, topicals and sterile injectables.
• Experience developing and maintaining high-quality technical documentation.
• Understanding of Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).
• Excellent problem-solving abilities with the ability to work efficiently in a fast-paced and collaborative setting.
• Excellent organizational and time-management skills, with the ability to prioritize tasks effectively and meet deadlines.
• Strong written and verbal communication skills, with attention to detail in documentation.