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  • Location

    Hoofddorp

  • Job title:

    Batch Record Reviewer

  • Sector:

    Biotechnology

  • Job ref:

    49510

  • Start Date:

    2022-11-01

About the company:

Our client is a biopharmaceutical company engaged in the development of cancer immunotherapies with the aim to provide long term response and eliminate this chronic disease, through innovative techniques as CAR T-cell therapy.


About the role:

As a Batch Record Reviewer, you will be in charge of reviewing the batches of the clinical products and provide the relative documentation and insights. 


Responsibilities:

• Review of completed manufacturing documentation per compliance standards and established timelines
• Perform all tasks associated with the manufacture of clinical product following batch records and SOPs
• Work as part of a small team to execute GMP runs in close collaboration with Product Sciences and Quality
• Successfully troubleshoot processing

Requirements:

• Comfortable in working 3-shifts
• Requires bachelors degree and/or advanced degree with a 3 or more years of cGMP experience in a manufacturing pharmaceutical/biotechnology environment
• Cell culture processing experience
• Previous experience with cell therapy products is a plus
• Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing, cell culture products
• Strict adherence to SOPs and cGMP regulations, the ability to accurately complete documentation associated with clinical manufacturing
• Excellent skill in Microsoft word, Excel and data analysis



Other info:

For this role an EU passport is required. No Intercontinental sponsorship possible. Are you ready to take a new step in your career? If you are interested please upload your resume using the apply button!