• QC Analyst II

    Location US-IL-Chicago
    Posted Date 2 weeks ago(12/5/2018 9:37 AM)
    ID
    2018-2245
    Company
    Adello Biologics, LLC
  • Overview

    Adello Biologics is a privately held, U.S.-based biotechnology company that leads with science to accelerate development and drive manufacturing efficiency. The company's aim is to provide high-quality, affordable biosimilars to patients worldwide. Headquartered in Piscataway, NJ and driven by a team of highly skilled industry veterans, Adello is advancing a strategic pipeline of proteins and complex monoclonal antibodies with lead candidates in oncology and immunology. For more information, visit www.Adellobio.com

     

    Our vision is to make biosimilar medications affordable. We are seeking candidates interested in contributing to a bourgeoning field that has the potential to help millions of patients. As a growing company, Adello Biologics offers real development opportunities for candidates excited to take on responsibility, make an immediate impact and help us achieve our vision. As part of a close knit team, you’ll have the opportunity to work in a unique, high science industry while expanding your career. We are seeking a QC Analyst II to be based out of our Chicago, IL location.

    Responsibilities

    SUMMARY:

    The Quality Control Analyst II will be responsible for analytical testing and data verification supporting both late-stage clinical and commercial biosimilar products in cGMP-compliant laboratories, and will also be expected to be engaged in continuous improvement initiatives to drive efficiency and effectiveness of Adello’s Quality Systems.  A background in protein chemistry is preferred in order to perform and troubleshoot techniques such as HPLC, SDS-PAGE, 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.

     

    Essential Duties and 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 preventive action plans.
    • Work with cross-functional teams to advance projects, maintain equipment, and author documents and reports.
    • Other laboratory and departmental activities as delegated by management.
    • A commitment to Adello’s Vision, Mission, and Values is essential.

    Qualifications

    PREREQUISITES:

    Education:

    • Bachelor’s degree in biotechnology, biochemistry, chemistry, or related field with a minimum of 8 years of experience in a pharmaceutical/biotech QC laboratory. Alternatively, Master’s degree in above areas with 6 years of experience in a pharmaceutical/biotech QC laboratory or PhD in above areas with a minimum of 2 years of experience.

     Experience:  

    • Previous experience in a cGMP laboratory.
    • Background in 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 HPLC, SDS-PAGE, cell-based bioassays, capillary electrophoresis, ELISA, and standard compendial assays.
    • Previous experience supporting regulatory inspections (e.g. PAI).
    • Familiarity with preparing regulatory dossiers and data packages for interactions between Adello and regulatory agencies.

     

       

    WORKING ENVIRONMENT/PHYSICAL REQUIREMENTS:

    General Working Environment:

    • 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 work extended hours or weekend hours, as may be required.

     

    Noise:

    • No extraordinary noise levels.

     

    Standing/Lifting:

    • Must be able to lift at least 25 lbs.

     

    Visual:

    • No extraordinary requirements.

     

    Stress:

    • High-paced demanding environment to meet ambitious project goals.

     

    Travel:

    • No travel required.

    Adello Biologics, LLC provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, Adello Biologics, LLC complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training

     

    Notice To Agency And Search Firm Representatives  

    Adello Biologics is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Adello employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Adello. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

     

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