Job Description

Kashiv BioSciences, LLC is a fully integrated biosciences company with an expanded and dynamic platform for growth including advanced drug delivery technologies, biosimilars, prodrugs, and a large development pipeline. We are looking for an experienced QC Analyst to join our Piscataway, NJ team!
 

The QC Analyst 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. This role will also be responsible for sample testing for functional characterization of biologics through various phases of biosimilar development. Techniques employed include but are not limited to cell-based assays, ELISA and SPR binding assays.  
 

A strong background in protein chemistry will be essential to perform and troubleshoot techniques such as UV, pH meter, HPLC, cell-based bioassays, capillary electrophoresis, 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.

Other essential responsibilities include:

• 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, such as raw material testing.
• Complies with all company policies and standards.
• Other duties as assigned.