Job Description

Quality Control Analytical Chemist II – Malvern, PA

Responsibilities:

• Calibrate, maintain and operator laboratory equipment such as HPLC, GC, GC-HS, FTIR, pH meter, balances, KF, titrators and LCMS
• Conduct GMP analyses of raw materials, in-process materials, final product, and stability samples
• Complete GMP documentation needed to support release of raw materials, intermediates, and final products
• Validate methods for use in GMP environment
• Prepare documents such as methods of analysis, specifications, analytical reports etc.
• Provide analytical support to Process R&D (synthetic R&D) group and collaborate to advance the project
• Participate in method development and optimization as necessary

Qualifications:

• Typically, BS w/ 3-5 years relevant experience or MS w/+2-year relevant experience in pharmaceutical industry. (or relevant fields)
• Previous QC/method development experience well considered
• Knowledge of cGMP regulations, USP, and chromatographic software is required.
• Excellent organizational, communication and documentation skills required.
• Prepositive approach and interest in analytical development, well considered.

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