Quality Control Supervisor- Biotechnology Operations
2 days ago
Quality Control Supervisor- Biotechnology Operations
DEMO AΒΕΕ
ΑΚΟΛΟΥΘΗΣΕ
Φαρμακευτικές & Κλάδος Υγείας
Προβολή 21 θέσεων
ΑθήναΤοποθεσία
Αθήνα
πριν 7 μέρες
Ημ. ανάρτησης
πριν 7 μέρες
Με κάποια εμπειρίαΕπίπεδο εμπειρίας
Με κάποια εμπειρία
Πλήρης απασχόλησηΤύπος απασχόλησης
Πλήρης απασχόληση
Επιστημονικός ΚλάδοςΚατηγορία θέσης
Επιστημονικός Κλάδος
At DEMO SA, one of the world's largest pharmaceutical manufacturers in injectable facilities, our new Biotechnology Center in Athens, Agios Stefanos, is now fully operational.
The field of Biotechnology is bringing about fascinating developments in medicine, treatments, and healthcare. Demo leads the way in the Greek pharmaceutical market with major investments in Biotechnology.
We are seeking an experienced and motivated Quality Control Supervisor to lead analytical operations in our biotechnology testing facility, ensuring regulatory compliance and advancing innovation across our QC laboratory.
Main duties and Responsibilities:
- Lead and mentor a team of analysts in performing QC operations and analytical testing to ensure product quality and compliance.
- Design, plan, and evaluate analytical method transfers, validations, and compendial method verifications, as well as stability studies.
- Author, review, and approve technical documentation including validation protocols, transfer reports, SOPs, and annual trending reports.
- Maintain and troubleshoot QC instrumentation to ensure optimal performance and regulatory adherence.
- Collaborate cross-functionally with Manufacturing, QA, and Analytical Development to support product release and continuous improvement initiatives.
- Provide technical guidance during analytical testing and method troubleshooting.
- Support regulatory submissions by preparing assay validation reports and other technical documentation in compliance with FDA, EMA, and other regulatory standards.
- Stay current with developments in analytical science and industry best practices, integrating novel technologies and methodologies to enhance QC performance.
- Contribute to training programs to strengthen technical capabilities and ensure GMP compliance within the team.
Requirements
- PhD or MSc in Chemistry, Biochemistry, or a related field.
- 6+ years of hands-on experience in Analytical Development or Quality Control within the pharmaceutical or biologics industry.
- Strong expertise in LC, GC, UV, and IR analytical techniques.
- Experience with CE-IEF, CE-SDS, ELISA, and qPCR is considered a strong asset.
- Proven experience working within a GMP-regulated environment and thorough understanding of regulatory requirements.
- Demonstrated leadership and team management skills.
- Excellent problem-solving, communication, and data-driven decision-making abilities.
Benefits
The Company offers competitive remuneration, continuous learning and development opportunities, and a friendly and challenging working environment.
Σχετικά tags
pharma industry
qualitycontrol
pharma
monoclonalantibodies
mabs
biosimilars
bioassay
bio
research and development
quality control
ΠΕΡΙΛΗΨΗ ΘΕΣΗΣ
Quality Control Supervisor- Biotechnology Operations
DEMO AΒΕΕ
ΑΚΟΛΟΥΘΗΣΕ
Αθήνα
πριν 7 μέρες
Με κάποια εμπειρία
Πλήρης απασχόληση
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