Jobs at Kashiv BioSciences LLC

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.

• 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.

Education:

• Bachelor's degree in biotechnology, biochemistry, chemistry, or related field with a minimum of 6 years of experience in a pharmaceutical/biotech QC laboratory.
• Alternatively, a master's degree in above areas with 4 years of experience in a pharmaceutical/biotech QC laboratory.

Experience:

• Previous experience in a cGMP laboratory.
• Strong background in Large/small molecule and protein chemistry and experience troubleshooting analytical results.
• Demonstrated success at writing, revising, and complying with SOPs, policies, and QC methods.

Specialized Knowledge and Skills:

• Demonstrated success working with techniques such as UV, pH meter, HPLC, cell-based bioassays, capillary electrophoresis, ELISA, and standard compendial assays.
• Strong experience with Empower data acquisition system.
• Previous experience supporting CMC submission.

Work Environment & Physical Demands:

• Some time spent in an office doing office work (reading, writing, reviewing, and editing documents).
• Significant amount of time spent in the laboratory.
• Must be able to lift at least 25 lbs.
• Must be able to work extended hours or weekend hours, as may be required.
• High-paced demanding environment to meet ambitious project goals.
• Minimal travel may be required.