Analytical Method Development and Validation, Scientist

Job Description

Company Description:

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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.

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Job Overview:

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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.

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Responsibilities:

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• Develop, validate, and transfer analytical methods for drug substances, drug products, related substances, and raw materials.

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• Perform both routine and complex analyses utilizing analytical techniques such as H/UPLC, GC-HS, Ion Chromatography, Atomic Absorption Spectroscopy, and related instrumentation.

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• Collaborate with R&D, Quality Control, and Regulatory Affairs teams to ensure product compliance with industry standards.

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• Interpret analytical data and prepare comprehensive reports for regulatory documentation and submissions.

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• Troubleshoot analytical methods and optimize procedures to enhance accuracy, precision, and efficiency.

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• Stay informed on the latest developments in analytical techniques, specifically related to small molecules, peptides, and sterile injectables, integrating relevant innovations into projects.

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• Train, mentor, and guide junior analytical staff in method execution and best laboratory practices.

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Qualifications:

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• Ph.D., Master’s, or Bachelor’s degree in Analytical Chemistry or a related discipline with emphasis on small molecule analysis.

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• Minimum of 6-10 years of relevant laboratory experience, ideally within the pharmaceutical or biotechnology sectors.

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• Solid understanding of advanced analytical chemistry theories and proven method development skills.

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• Proficiency with analytical instrumentation such as H/UPLC, GC-HS, Ion Chromatography, and Atomic Absorption Spectroscopy.

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• Familiarity with regulatory requirements (FDA, ICH guidelines) pertinent to analytical method development and validation.

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• Strong ability to independently manage projects, meet deadlines, and prioritize tasks effectively.

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• Exceptional problem-solving capabilities and experience in leading analytical investigations.

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• Excellent written and verbal communication skills for clear and concise presentation of complex data.

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• Proven ability to work collaboratively in a dynamic, multidisciplinary environment.

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• Demonstrated experience in GMP settings and practical knowledge of their application to pharmaceutical development.

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Location: Fairfield, NJ

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Position Type: Full-Time, On-Site

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

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