Analytical Method Development and Validation, Scientist

Stira Pharmaceuticals is a Sterile Injectable CDMO specializing in pharmaceutical product development and the manufacturing of small molecules and peptides. Our expert scientific team utilizes advanced in-house technology platforms combined with extensive industry experience to tackle challenging product developments. We offer comprehensive services including Analytical R&D, Preformulation, Formulation Development, Manufacturing, and Regulatory Support.

Stira Pharmaceuticals, LLC, located in Fairfield, NJ, seeks a motivated and detail-oriented Analytical Scientist for a full-time, on-site role. The successful candidate will develop, validate, and transfer analytical methods for drug substance and drug products with a specific focus on related substances. This role requires adherence to cGMP guidelines and collaboration across multiple functional teams.

• Develop, validate, and transfer analytical methods for drug substances, drug products, related substances, and raw materials.
• Perform both routine and complex analyses utilizing analytical techniques such as H/UPLC, GC-HS, Ion Chromatography, Atomic Absorption Spectroscopy, and related instrumentation.
• Collaborate with R&D, Quality Control, and Regulatory Affairs teams to ensure product compliance with industry standards.
• Interpret analytical data and prepare comprehensive reports for regulatory documentation and submissions.
• Troubleshoot analytical methods and optimize procedures to enhance accuracy, precision, and efficiency.
• Stay informed on the latest developments in analytical techniques, specifically related to small molecules, peptides, and sterile injectables, integrating relevant innovations into projects.
• Train, mentor, and guide junior analytical staff in method execution and best laboratory practices.

• Ph.D., Master’s, or Bachelor’s degree in Analytical Chemistry or a related discipline with emphasis on small molecule analysis.
• Minimum of 6-10 years of relevant laboratory experience, ideally within the pharmaceutical or biotechnology sectors.
• Solid understanding of advanced analytical chemistry theories and proven method development skills.
• Proficiency with analytical instrumentation such as H/UPLC, GC-HS, Ion Chromatography, and Atomic Absorption Spectroscopy.
• Familiarity with regulatory requirements (FDA, ICH guidelines) pertinent to analytical method development and validation.
• Strong ability to independently manage projects, meet deadlines, and prioritize tasks effectively.
• Exceptional problem-solving capabilities and experience in leading analytical investigations.
• Excellent written and verbal communication skills for clear and concise presentation of complex data.
• Proven ability to work collaboratively in a dynamic, multidisciplinary environment.
• Demonstrated experience in GMP settings and practical knowledge of their application to pharmaceutical development.

Fairfield, NJ

Full-Time, On-Site

• We invite talented individuals committed to scientific excellence and innovation to join our dynamic team at Stira Pharmaceuticals.