Job Description

The QC Analyst IV will be responsible for analytical testing and data verification supporting both late-stage clinical and commercial small molecule and biosimilar products in cGMP-compliant laboratories.  A strong background in protein chemistry will be essential to perform and troubleshoot techniques such as HPLC, SDS-PAGE, cell-based bioassays, capillary electrophoresis, SDS-PAGE, ELISA, and standard compendial assays.  A demonstrated ability to collaborate across multiple departments to drive timely resolution of projects, laboratory investigations, and process improvements is required.

Essential Duties & Responsibilities

• Analytical testing to support product in-process, release, and stability programs.

• Strong knowledge of cGMP, Quality Systems, and ICH / regulatory guidance.

• Conduct, compile, and/or review Out of Specification lab investigations, deviations, and corrective and preventative actions plans.

• Work with cross-functional teams to advance projects, maintain equipment, and authoring of documents and reports.

• Performs other functions as required or assigned

• Complies with all company policies and standards