Analytical Scientist

Job Description

Job Summary

The Analytical Scientist I will support API development programs through analytical method development, optimization, qualification, and validation. This role will perform laboratory experiments, analyze data, troubleshoot analytical equipment, and prepare technical documentation in compliance with cGMP, SOPs, and regulatory requirements.

Responsibilities

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• Develop, optimize, qualify, and validate analytical methods for drug substances.
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• Execute experiments using techniques such as HPLC, GC, GC-HS, FTIR, KF, XRPD, particle size analysis, and HPLC-MS.
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• Analyze and interpret experimental data and recommend appropriate follow-up activities.
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• Prepare analytical methods, development reports, protocols, and validation documentation.
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• Perform routine equipment maintenance and troubleshooting.
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• Conduct literature searches and apply scientific principles to resolve analytical challenges.
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• Manage assigned analytical project activities and provide updates to internal and external stakeholders.
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• Coordinate activities with contract analytical and testing laboratories as needed.
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• Maintain compliance with cGMP, SOPs, training, and applicable regulatory requirements.
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Qualifications

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• Bachelor’s degree in Analytical Chemistry or related scientific discipline with 4+ years of experience; or
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• Master’s degree with 2+ years of industrial experience; or
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• Ph.D. with 0–1+ years of industrial experience.
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• Hands-on experience with analytical method development, qualification, or validation.
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• Strong knowledge of analytical techniques, particularly HPLC and GC .
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• Understanding of cGMP requirements and analytical laboratory practices.
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• Strong data analysis, technical writing, and problem-solving skills.
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• Ability to work independently and collaboratively in a fast-paced environment.
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• Proficiency with Microsoft Office and standard IT systems.
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• Strong communication skills and ability to work effectively with internal teams and external customers.
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• Up to 5% travel required.
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