QC analyst CAR-T Biotech

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Learn more at QC analyst CAR-T Europe is responsible for preparing and conducting test of the different samples taken during the production process. You are responsible for ensuring testing is completed in compliance with all applicable procedures standards and GMP regulations.

This role is based on a weekend shift: Saturdays and Sundays from 6:00 to 18:00 h.

Your responsibilities:

• Perform analytical testing in compliance with all applicable specifications procedures GMP Regulations

• Maintain a safe work environment in compliance with all applicable environmental health and safety Regulations

• Perform peer review of laboratory data Author and update SOPs WIs and Protocols to support daily operations of the lab using the document management system

• Support laboratory related investigation records and CAPAs Assist in the execution of internal audits

• Provide input to functional laboratory meetings

• Provide input and take actions as a QC representative at cross-laboratory meetings

SHE responsibilities:

• Always strictly apply all applicable prevention rules and procedures

• Make correct use of the personal and collective protective equipment provided

• Ensuring order and tidiness

• Reporting (near) accidents incidents deviations and risky situations

• Contributing to and proposing solutions to improve safety health and the environment

• Actively taking part in promotional campaigns

• Addressing other employees and third parties when prevention procedures are not followed or when unsafe behavior is reported

Requirements & Qualifications

• A minimum of a bachelors in a Scientific or related field is required

• A minimum of two (2) years of experience working in a cGMP compliant QC laboratory or equivalent is required.

• Understanding of analytical data generated from performing biological and biochemical analytical techniques is required.

• Detailed knowledge of analytical technologies used in the QC laboratory (CAR-T experience) is required

• Experience in performing cellular and/or molecular based techniques such as qPCR Flow Cytometry and/or Potency assays is required

• Basic knowledge of compendial (USP EP JP etc.) requirements pertaining to their functional area of QC is preferred

• Proficient with using Microsoft Office applications (Outlook Excel Word and PowerPoint) is required.

• Excellent written and oral communication skills are required

At Johnson & Johnson we want every candidate to feel supported throughout the hiring process. Our goal is to make the experience clear fair and respectful of your time.

Required Skills:

Preferred Skills: