QC Analyst (All Levels)

Company: Kashiv Biosciences LLC
Location: Piscataway
Posted on: March 19, 2023

Job Description:

Description:
Visa Sponsorship Not Available
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.
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.Requirements: 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, 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.Benefits:
          • Medical
          • Dental
          • Vision
          • 401K
          • Commuter/Transit
          • Student Loan Assistance
          • Cell Phone AllowanceThis position description is not a complete list of all responsibilities, duties or skill required for the job and is subject to review and change at any time, with or without notice, in accordance with the needs of the organization.
            
            
            
            PI207717896

Keywords: Kashiv Biosciences LLC, Trenton , QC Analyst (All Levels), Professions , Piscataway, New Jersey