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Quality control specialist - protein analytics (m/f/d)

Stockheim
AveThera GmbH
Inserat online seit: 12 Mai
Beschreibung

The Company AveThera GmbH is an innovative biopharmaceutical company specializes in the development biotechnologically produced pharmaceuticals, with a focus on biosimilars. With two development and GMP compliant manufacturing sites for biopharmaceutical products located in Henningsdorf and Braunschweig, we are seeking a candidate to join our Protein Analytics team in the Quality Control department at our Braunschweig location as soon as possible. QC Scientist / QC Specialist (m/f/d) Planning and conducting product-specific quality control in collaboration with the QC team for characterization, release, and stability studies Supervising staff (technical assistants, engineers) Development and validation of methods for product-specific analysis of pharmaceutical proteines (HPLC, CE, HILIC, MS, ELISA, bioassays, etc.) Preparation of standard operating procedures, test instructions, protocols, and reports in a GMP-regulated environment Preparation of stability test instructions, and performance and evaluation of stability tests in accordance with ICH guidelines Participation in inspections and regulatory audits A completed degree (Master’s/Diploma or Ph.D.) in biochemistry, biotechnology, pharmacy, biology, or chemistry 3-5 years of professional experience in a pharmaceutical or biotechnology setting, preferably in the quality control of biological active ingredients Extensive experience across the full range of protein analytical methods Experience in the development and validation of analytical methods Several years of experience in a GMP-regulated environment Ability to work independently, with precision, in an organized and goal-oriented manner High level of flexibility Ability to work well in a team, strong interpersonal skills, and excellent communication skills Fluent in spoken and written German and English A dynamic, international environment where you can quickly take on significant responsibilities, contribute your experience and knowledge, and bring your ideas to life Diverse challenges and exciting projects with a strong team spirit Excellent Benefits Flexible Working Times Optimal induction and training opportunities as well as individual development options Flat hierarchies, short decision-making processes and flexibility

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