8 дней назад
QC Analyst CAR-T (Biotech)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
QC Analyst CAR-T (Biotech) (GMP/Cellular and Molecular Testing): Performing quality control testing for final CAR-T drug product release, stability studies, and incoming lentiviral batch identification with an accent on GMP compliance, data integrity, and biological analytical methods. Focus on qPCR, flow cytometry, potency assays, laboratory investigations, audit readiness, and maintaining compliant QC operations.
Location: Beerse, Antwerp, Belgium; onsite role
Salary: €0.00–€0.00 anticipated base pay range
Company
Healthcare and MedTech organization developing innovative medicines and solutions for complex diseases.
What you will do
- Perform GMP-compliant analytical testing for final drug product release, stability studies, and incoming lentiviral batch identification.
- Conduct peer review of laboratory data and ensure accuracy, compliance, and data integrity.
- Author, revise, and maintain SOPs, work instructions, and protocols as a QC subject matter expert.
- Support investigations, deviations, CAPAs, equipment qualification, calibration, and maintenance.
- Participate in audits, inspection readiness activities, laboratory meetings, and cross-functional collaboration.
- Deliver training and promote a safe, organized, and compliant laboratory environment in accordance with SHE standards.
Requirements
- Bachelor’s degree in a scientific discipline or related field.
- At least 2 years of experience in a cGMP-compliant Quality Control laboratory or similar regulated environment preferred.
- Experience with cellular or molecular analytical techniques, including qPCR, flow cytometry, and potency assays.
- Strong knowledge of biological and biochemical analytical testing, QC laboratory technologies, and preferably compendial requirements such as USP, EP, and JP.
- Proficiency in Microsoft Office applications, including Outlook, Excel, Word, and PowerPoint.
- Excellent written and verbal English is required; Dutch is an advantage. Flexibility for future early and late shifts may be required.
Nice to have
- CAR-T experience.
- Knowledge of compendial requirements including USP, EP, and JP.
- Dutch language skills.
Culture & Benefits
- Inclusive and respectful work environment focused on patient impact and healthcare innovation.
- Annual bonus with a target depending on pay grade and location.
- Vacation, parental, bereavement, caregiver, and volunteer leave.
- Well-being reimbursement and financial, physical, and mental health programs.
- Insurance plans, service anniversary awards, and recognition programs subject to plan terms and location.
Hiring process
- Application and CV review.
- Short call with the recruitment team.
- Country-specific checks before starting the role, with guidance provided during the process.
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