As an Analytical Chemist II, you will play a key role in conducting GMP analyses on raw materials, in-process materials, final products, and stability samples. You will also be responsible for generating documentation to support the release of GMP materials. In this role, you will contribute to the development and validation of analytical methods, prepare related documentation, and collaborate with the Process R&D (Synthetic R&D) team on project advancements.
Key Responsibilities:
- Operate, maintain, and calibrate laboratory equipment such as HPLC, GC, GC-HS, FTIR, pH meters, balances, KF titrators, and LCMS.
- Perform GMP analyses on raw materials, in-process materials, final products, and stability samples.
- Complete GMP documentation necessary to support the release of raw materials, intermediates, and final products.
- Validate analytical methods for use in a GMP environment.
- Prepare documentation, including methods of analysis, specifications, and analytical reports.
- Provide analytical support to the Process R&D (Synthetic R&D) team and collaborate to advance projects.
- Participate in method development, optimization, and validation as needed.
Qualifications:
- BS degree with 3-5 years of relevant experience, or MS degree with 2+ years of relevant experience in the pharmaceutical industry (or related fields).
- Experience in quality control and method development is highly valued.
- Knowledge of cGMP regulations, USP, and chromatographic software is required.
- Strong organizational, communication, and documentation skills are essential.
- A proactive mindset and interest in analytical development are highly regarded.