6 дней назад
QC Shift Lead Weekend Biotech
61 115 - 82 685€
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
QC Shift Lead Weekend Biotech (Biotech/QC): Leading weekend quality control operations for CAR-T release laboratories, including Flow Cytometry, Molecular Assay qPCR, and ELISA testing, with an accent on GMP compliance, laboratory data accuracy, and team development. Focus on reviewing analytical data, managing OOS investigations and CAPAs, maintaining compliant procedures, and coordinating QC activities with Quality Assurance, Manufacturing, and Technical Operations.
Location: Beerse, Antwerp, Belgium; based at the Janssen Beerse site and accommodating a weekend shift schedule.
Salary: €61,115–€82,685 per year.
Company
Johnson & Johnson MedTech and Janssen Supply Chain develop healthcare solutions and support CAR-T manufacturing and quality operations in Europe.
What you will do
- Lead and develop the weekend QC Biotech team across Flow Cytometry, Molecular Assay qPCR, and ELISA laboratories.
- Plan testing priorities, assign work, manage training completion, and act as the weekend shift point of contact.
- Review and approve laboratory data for validity and accuracy in accordance with cGMP and cGLP standards.
- Prepare and perform analytical testing of production samples in compliance with specifications, procedures, and GMP regulations.
- Support investigations of OOS and invalid assays, CAPAs, change controls, audits, and laboratory procedure updates.
- Collaborate with Quality Assurance, Manufacturing, Technical Operations, Engineering, Maintenance, and contract laboratories.
Requirements
- Bachelor’s degree in Engineering, Science, or an equivalent technical discipline.
- 3–5 years of professional experience and expert knowledge of QC analytical technologies, including flow cytometry, ELISA, qPCR, NC200, and cell culture.
- Detailed knowledge of cGMP requirements, ICH Q7, 21 CFR Parts 210, 211, 600, 601, and 610, and compendial standards such as USP, EP, and JP.
- Experience identifying and remediating quality gaps, reviewing laboratory data, and supporting method transfer.
- Availability to work the weekend shift and on-site in Beerse, Belgium.
- Proficiency with Microsoft Office applications is required.
Nice to have
- Three or more years of supervisory experience.
- Experience in method development, cell banking, research and development, or cell and gene therapy.
- Experience with reagent qualification and management, LIMS, or SAP.
Culture & Benefits
- Inclusive work environment focused on employee dignity, diversity, and individual development.
- Opportunity to support CAR-T treatments and quality operations for innovative medicine.
- Work with cross-functional partners across quality, manufacturing, technical operations, engineering, and maintenance.
Hiring process
- CV and application review.
- Short call with the recruitment team.
- Country-specific checks before starting the role.
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