Noch 15 Std. zum Bewerben!: Director Biologics (Head of Quality Control-Analytics) (m/f/d)

DescriptionLead, manage, and develop multiple laboratory teams, fostering a culture of excellence and continuous improvementReport directly to senior management on all HQC and operational activities, ensuring alignment with company goalsOversee protein analytical methods, including method development, release testing, and stability studiesManage a diverse method portfolio including (U)HPLC-SEC, -IEX, RP-HPLC, LC/MS, amino acid analysis, and analytical ultracentrifugationSupervise all quality control systems, ensuring compliance with GMP, ICH and AMWHV regulations and functioning as the Head of Quality ControlEnsure the release of laboratory results, including overseeing method transfers and co-validations according to ICH guidelinesEnsure the writing, review, and approval of GMP documents, including SOPs, plans, reports, deviations, changes, OOS, etc.Maintain strict adherence to regulatory guidelines, supporting quality audits and inspectionsSupport the development and optimization of biologic methods, utilizing Design of Experiment (DOE) and other advanced methodologies to determine identity and purityDrive the implementation of new technologies and automation in QC processes to enhance efficiency and accuracyOversee the efficient and economic management of the laboratory, optimizing processes to meet project timelines and customers’ expectationsParticipate in personnel and budget planning, ensuring resources are effectively allocatedWork closely with cross-functional teams, including R&D, Manufacturing, and Regulatory Affairs, to meet project objectives and ensure timely delivery of analytical reportsRequirementsPhD or master’s degree in Biochemistry, Molecular Biology, Biotechnology, or a related fieldA minimum of 4 years of experience in Quality Control within the (bio)pharmaceutical industry in a GMP environment, with at least 2 years in a leadership roleExperience with an extensive portfolio of protein and peptide analytical techniques, including (U)HPLC-SEC, -IEX, RP-HPLC, LC/MS, amino acid analysis, and analytical ultracentrifugationExtensive knowledge of biologics manufacturing, analytical techniques, and regulatory requirements (GMP, FDA, EMA, etc.)Proven experience in managing and developing high-performing QC teamsStrong analytical and problem-solving skills, with a track record of successful investigations and CAPA implementationExcellent communication and interpersonal skills, with the ability to influence and collaborate across all levels of the organizationExperience with QC laboratory management, including equipment qualification and method validationProficiency in data analysis software and Laboratory Information Management Systems (LIMS)Strong organizational skills with the ability to manage multiple projects and priorities in a fast-paced environmentEconomic thinking and experience in dealing with laboratory key figuresWe offerResponsible and varied tasks in a motivating working environmentA permanent position in a dynamically growing international life science group with over 200 employeesOptimal induction and training opportunities as well as individual development options Appreciation, openness and respect as well as a lively feedback cultureFlat hierarchies, short decision-making processes and flexibility Comprehensive health management Job-Bike leasingRegular company and team eventsCategoryOperations