Quality Control Team Leader
vor 3 Wochen
Biosynth is a critical materials provider that secures the supply chains of the life science and pharmaceutical industries with global research, manufacturing and distribution facilities. With a unique research product portfolio of more than one million products and comprehensive manufacturing services, Biosynth has expertise and capabilities in the areas of complex chemicals, peptides and key biological products. Biosynth AG is headquartered in Staad, Switzerland .At its Berlin location, Biosynth GmbH carries out contract development and manufacturing in the field of bioconjugation and polymer-based administration of active ingredients.We are looking for a QC Team Lead to support the QC Manager in ensuring smooth daily operations of the Quality Control team. This role is ideal for someone with strong technical knowledge, leadership skills, and an interest in both lab work and team coordination.Main Accountabilities and ResponsibilitiesThe QC Team Leader may effectively run several laboratory projects at a time including routine QC analysis on raw materials and finished products (including drug substance and drug products) as well as developing new methods.Daily routine will involve distribution of work and checking and releasing of data ensuring quality and reliability. Support and guide the QC team on daily tasks and workflowsCommunicate with other departments and check data for R&D and GMP sample releaseManage QC documentation, SOPs, and QMS processesMaintain and support calibration and qualification of analytical equipmentCarry out analytical testing using wet chemistry and instrumental techniquesDevelop and improve analytical methods for raw materials and products including its corresponding SOPsMentor team members, monitor performance, and ensure accountabilityEssential Candidate RequirementsBSc or higher degree in analytical chemistry, chemistry, biochemistry or relatedExtensive experience (7+ years) in an analytical (bio-)chemistry laboratoryExperience in handling and analysing proteins and/or peptides and derivativesProficient atanalytical method development especially chromatographic methodsProven line management experience, especially in direct instruction of laboratory personnel Experience in the preparation of laboratory documents and documentation (e.g. analytical reports, work instructions, etc.)Good communication skills including competency and willingness to instruct skilled laboratory analysts in a cooperative mannerStrong problem-solving skills and attention to detail, highly motivated to implement new and improve existing laboratory processes, willingness to continuously improve understanding of operating a GMP-compliant testing labStrong analytical interpretationAt least upper intermediate (≥ B2) language proficiency in German and English, both verbally and in writing Desirable Candidate RequirementsAnalytical techniques: HPLC, UV/VIS photometry, ELISA or microplate assays, IEF- and SDS-PAGE, MALDI-ToF-MS, and IRKnowledge in equipment requalification, calibration, servicing etc. Trouble shooting of the analytical equipmentValidation of analytical methodsExperience with regulated lab (GMP/GXP or ISO 9001) standardsAbout usBiosynth® is an innovative life sciences reagents, custom synthesis and manufacturing services company headquartered in Staad, Switzerland. We are by scientists, for scientists, securing supply chains with consistent quality, across the globe. As a trusted supplier, manufacturer and partner to the pharmaceutical, life science and diagnostic industries, as well as food, agrochemical and cosmetic customers, we have facilities on three continents and a rapid global distribution network. Our main production laboratories are located in Switzerland, the UK, Slovakia and China, with peptide and antibody production in the US, the Netherlands. Bioconjugation projects are carried out in Germany, Enzyme projects are based in Austria and biological IVD reagents in Ireland.Recruitment agencies - We do not use external recruitment agencies to recruit for any of our positions. We will not accept unsolicited CVs and communications from external recruiters.
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