Job Description

Position Summary

The Analytical Scientist is responsible for performing a wide range of tests to assess the quality of raw materials, in-process materials, finished products, and cleaning verification/validation samples to ensure compliance with established regulatory and company standards. This role leads analytical method development and validation activities, conducts both routine and non-routine testing, and plays a key role in laboratory investigations, documentation, and reporting. The position also serves as a technical liaison with clients, supporting method development, data interpretation, and investigative efforts.

Key Responsibilities:

• Conduct and validate analytical testing of raw materials, intermediates, finished products, environmental samples, and stability batches.
• Develop, validate, and implement new analytical methods, including those for cleaning verification (e.g., via HPLC).
• Author detailed analytical protocols, validation reports, and Certificates of Analysis.
• Troubleshoot analytical methods and laboratory equipment.
• Compile, interpret, and document analytical data following cGMP standards.
• Maintain accurate laboratory records including notebooks, worksheets, and batch records.
• Review and peer-check laboratory documentation for accuracy and compliance.
• Lead investigations into Out-of-Specification (OOS) and Out-of-Tolerance (OOT) results, and communicate findings per SOPs.
• Support environmental monitoring efforts as needed.
• Train and lead a team of analytical scientists and technicians.
• Ensure adherence to SOPs, cGMP, ICH, USP/EP, ISO, and regulatory guidelines (21 CFR Parts 210, 211, and 820).
• Interact with clients regarding laboratory activities, including method development and investigation outcomes.
• Perform other related duties as assigned.

Qualifications:

• Bachelor’s degree in Chemistry or a related scientific field.
• 2-4 years of analytical laboratory experience.
• Extensive knowledge of cGMP, FDA (21 CFR Parts 210, 211, 820), ICH, EU, and ISO standards.
• Strong expertise in pharmacopeial requirements (USP, EP, etc.).
• Experience in specialized testing such as dissolution or aerosol analysis is preferred.
• Proven ability to develop and validate complex analytical methods.
• Excellent written and verbal communication skills, including the ability to present findings internally and externally.
• Highly skilled in Microsoft Office (Word, Excel, PowerPoint, Outlook).
• Strong organizational skills, attention to detail, and manual dexterity.
• Ability to interpret and follow complex documents such as SOPs, protocols, and regulatory guidelines.
• Capable of clear and effective communication with internal teams and external clients.
• Proficient in applying arithmetic and basic statistical concepts to analytical processes.

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