Unleash Your Analytical Expertise in a Cutting-Edge Role!

Are you passionate about chemistry and ready to make a real impact in the world of R&D? We are a specialized pharmaceutical manufacturing company seeking an Analytical Chemist to play a key role in ensuring the quality and compliance of groundbreaking products. From developing innovative HPLC methods to troubleshooting complex analytical challenges, you’ll be at the forefront of scientific excellence!

SUMMARY/OBJECTIVE:

Support R&D scientists by performing analytical tests to ensure the quality and compliance of raw materials, in-process materials, finished products, and cleaning samples. Contribute to method development, validation, and troubleshooting as needed.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Conduct routine and non-routine chemical analyses on raw materials, in-process, finished goods, and environmental samples.
• Develop, validate, and troubleshoot analytical methods, including HPLC for cleaning verification.
• Collect, analyze, and document cleaning verification/validation samples.
• Prepare and maintain raw data, Certificates of Analysis, and analytical reports.
• Peer-review laboratory records and ensure compliance with SOPs, cGMPs, and regulatory standards.
• Communicate quality or compliance concerns and support OOS/OOT investigations.
• Assist with environmental monitoring activities as required.
• Perform additional duties as assigned.

QUALIFICATIONS:

• Bachelor’s Degree in Chemistry or related field with 2+ years of analytical laboratory experience.
• Proficiency in HPLC method development (2+ years).
• Knowledge of cGMPs, EU, 21 CFR Part 210/211/820, and ISO standards.
• Strong understanding of USP, EP, and other pharmacopeia.