6 дней назад
QC Analyst (CAR-T Biotech)
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
QC Analyst (CAR-T Biotech) (GMP/Cellular Analytics): 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
Company
Johnson & Johnson MedTech develops healthcare solutions and innovative medicines designed to prevent, treat, and cure complex diseases.
What you will do
- Perform GMP-compliant analytical testing for final drug product release, stability studies, and incoming lentiviral batch identification.
- Review laboratory data for 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, compliant laboratory environment in line 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 such as qPCR, flow cytometry, and potency assays.
- Knowledge of biological and biochemical testing, QC laboratory technologies, and preferably USP, EP, or JP compendial requirements.
- Proficiency in Microsoft Office, including Outlook, Excel, Word, and PowerPoint.
- Excellent written and verbal English communication skills required; Dutch is an advantage. Flexibility for future early and late shifts may be required.
Nice to have
- CAR-T experience.
- Dutch language skills.
Culture & Benefits
- Inclusive work environment focused on individual dignity, diversity, and employee contribution.
- Annual bonus with a target based on pay grade and location, subject to performance.
- Vacation, parental, bereavement, caregiver, and volunteer leave.
- Well-being reimbursement and financial, physical, and mental health programs.
- Recognition awards and access to applicable insurance plans.
Hiring process
- Application and CV review.
- Short recruitment call for matched candidates.
- Country-specific checks before starting the role.
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