Summary
About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine
Description
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com
Job Function:
QualityJob Sub Function:
Quality ControlJob Category:
Business Enablement/SupportAll Job Posting Locations:
BE009 Turnhoutseweg 30Job Description:
We are searching for the best talent for QC CAR-T Trainer Expert to be in Gent,
Belgium.
The Janssen Supply Chain Group, a member of the Johnson & Johnson family of companies, is recruiting QC CAR-T Trainer Experts for the CAR-T hub in Europe. The position will be based in Beerse Belgium.
CAR-T (chimeric antigen receptor T-cell therapy) is a new way to treat cancer, which work by harnessing the power of a patient’s own immune system. They are built from the patients’ own T cells and are engineered to eliminate cancer cells expressing a specific antigen.
To support the CAR-T program in EMEA, Janssen has built two CAR-T manufacturing centers in the Ghent area (Belgium). The QC laboratories operate from the existing Janssen Beerse site.
The QC CAR-T Trainer Expert is responsible for preparing and coaching newly onboarded QC CAR-T analysts. The QC analysts perform QC release/stability testing of the different samples taken during the production process or perform qualification of critical reagents applied in the QC release analyses. You are responsible for ensuring that trained and qualified analysts perform testing in compliance with all applicable procedures, standards, and GMP regulations.
You will be responsible for:
- Mentor analysts in performing analytical testing in compliance with all applicable specifications, procedures, GMP regulations.
- Maintain a safe work environment in compliance with all applicable regulations.
- Provide QC analysts theoretical background on CAR-T and QC related analytical methods.
- Train QC analysts in QC related analytical methods being used in CAR-T release.
- Author and update SOPs, WIs and Protocols to support daily operations of the lab using the Document Management System.
- Support complex laboratory related investigation records, CAPAs and assist in complex laboratory investigation issues by demonstrating strong reasoning skills.
- Assist in the execution of internal audits.
- Provide input to functional laboratory meetings.
Qualifications & Requirements:
- A master degree in engineering, medical science or a similar technical field or a bachelor degree accompanied by appropriate additional years of experience
- Detailed knowledge of Flow cytometry, ELISA, qPCR and cell culture with hands-on experience is required.
- Understanding of analytical data generated from performing biological and biochemical analytical techniques is required.
- Experience in mentoring people is required.
- Proficient with using Microsoft Office applications (Outlook, Excel, Word, and PowerPoint) is required.
- Strong communication and interpersonal skills, a high level of organizational ability, attention to detail, and ability to work effectively in a collaborative environment globally (US and EU) is required.
- The candidate must be highly organized and capable of working in a team environment with a positive mentality under some supervision.
- Knowledge of cGMP regulations and FDA/EU guidance is preferred.
- Comfortable with speaking and interacting with inspectors.#RPOAMS
