KB QC Analyst III - Bioassay

Amneal India • Piscataway, NJ

1d • $93,000 - $123,000 • Onsite

About The Position

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.

Requirements

• Bachelor’s degree in biotechnology, biochemistry, chemistry, or related field with a minimum of 6 years of experience in a pharmaceutical/biotech QC laboratory.
• Master’s degree in biotechnology, biochemistry, chemistry, or related field with 4 years of experience in a pharmaceutical/biotech QC laboratory.
• 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.
• 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.

Responsibilities

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

Benefits

• short-term incentive opportunity, such as a bonus or performance-based award
• long-term incentive award, such as restricted stock units
• comprehensive, flexible and competitive benefits program
• above-market, diverse and robust health and insurance benefits
• significant 401(k) matching contribution
• programs that help you enjoy your career alongside life’s many other commitments and opportunities

What This Job Offers

• Job Type: Full-time
• Career Level: Senior