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    Reference number: 778889/1

    Scientist Product Characterization (m/f/d)

    Employment with Hays Professional Solutions GmbH
    Marburg
    • Develop and qualify robust, fit-for-purpose analytical mass-spectrometry methods and optimize existing LC-MS and LC-MS/MS methods to support development activities of Recombinant Product Development
    • Execute method development, qualification and/or optimization studies following QbD principles where applicable
    • Prepare assay test procedures and assay qualification protocols for new test methods for approval by a Senior Scientist/Manager (e.g. peptide mapping, intact mass and middle down)
    • Plan and execute analytical studies/ routine MS-analyses to support process development activities, product comparison and physico-chemical characterization activities (e.g. Comparability Studies, Forced Degradation Studies)
    • When required perform routine analysis of samples using assays such as (but not limited to) SDS-PAGE, Western Blots, HPLC based assays (e.g. SE-HPLC, RP-HPLC, AIX-HPLC), glyco-profiling
    • Prepare scientific reports detailing assay development and qualification studies or other analytical studies and present analytical data to key stakeholders
    • Implement and support quality systems within the group and ensure department compliance with scientific standards
    • Support the maintenance of laboratory and analytical equipment. Liaise with instrument engineers and/or external service providers for maintenance of equipment
    • Participate in the selection of equipment for purchase, write user requirements and prepare purchase orders
    • Follow safety standards as governed by local, state and federal regulations, laws and policies as well as companiy policies and directives.
    Online since: Fri Aug 16 14:17:17 CEST 2024
    Reference number: 782272/1

    QSP Project Scientist (m/f/d)

    Freelance/Contracting project
    Remote
    • Serves as the lead PKPD/ ADME/QSP project scientist for a variety of programs and drug modalities; biologics, small molecules and novel platforms such as cell- and gene-therapy, gene-editing, and non-viral gene delivery
    • Serves as technical expert for the PK/QSP organization in the application of advanced PK/PD, mechanistic, and disease modeling principles and methodologies,
    • Performs advanced PK/PD modeling utilizing mechanistic and semi-mechanistic approaches to define the dose-concentration-efficacy/toxicity relationships, formulate various study design scenarios, and outcome prediction, to inform decision making,
    • Leads study design discussions, study protocols development, including sample size calculations, data analysis plan, and report population PK and PK/PD analysis results to management and review committees
    Online since: Thu Sep 12 11:02:55 CEST 2024
    Reference number: 784925/1

    Senior Scientist Research & Development (m/f/d)

    Permanent employment with our customer
    Bremen
    • Conception and implementation of feasibility experiments to demonstrate the proof of principle of new development concepts
    • Ensure high experimental quality and deep theoretical penetration throughout all stages of product development, from research to serial production
    • Embrace and overcome complex or novel challenges by developing effective solutions and execution strategies highlighting your problem-solving abilities
    • Collaborate closely with your colleagues to create control software for hardware components
    • Generate documentation as part of the development process, ensuring clear and comprehensive documentation
    • Apply principles, rules, and strategies related to intellectual property when drafting invention disclosures, patents, publications, and presentations, ensuring the protection of innovative ideas and technologies
    • Communicate development status verbally in internal meetings and with external collaborators
    • Proven ears industrial or years academic experience (Ph.D.) in development of sophisticated analytical instrumentation or related technologies
    • Experience in the evaluation of analytical instrumentation based on ion optical techniques from the initial design of experiments to analysis of results
    • Hands on testing and troubleshooting of mechanical and electronic components
    • Understanding of ion optical design, ion or particle simulations in electrical, magnetic and/or gas fields would be appreciated
    • Strong flexibility to work collaboratively in a team as well as independently and structured in a detailed scientific manner
    Online since: Wed Sep 25 09:35:20 CEST 2024
    Reference number: 791734/1

    Digital Biomarker - Data Scientist (m/f/d)

    Freelance/temporary employment for a project
    Basel Stadt
    • Analyze clinical and digital biomarker data from various studies to develop and improve our digital biomarker solutions
    • Support the digital biomarker evidence generation activities with statistical modeling and analysis expertise
    • Be responsible for a work package: break down a business question into planned work, following up of work in progress, risk assessment, communicating on progress and results, reading literature, writing reports and publications 
    • Contribute to development and maintenance of statistical analysis pipelines
    Online since: Wed Nov 06 14:42:27 CET 2024
    Reference number: 780194/1

    Senior Scientist Tech transfer (m/f/d)

    Freelance/temporary employment for a project
    Neuchatel
    • Responsible for supporting commercial manufacturing performance at the external manufacturing site
    • Represents MS&T external manufacturing team to provide technical support to the biological drug substance tech transfer process including deviation resolution, change management, delivery of yield targets and process optimization
    • Maintains strong working relationships with external and internal partner
    • Interface with internal functions such as MS&T, Quality, and Supply Chain
    • Develop and maintain strong technical familiarity with process and process equipment, process optimization evolution and technical problem solving
    • Tracks progress of routine manufacturing against schedule, provides routine updates and proactively identifies operational risks and remediation
    • Ensures timely escalation of potential technical, compliance or safety issues to the MS&T team and partners with internal MS&T resources to remediate
    • Ensures effective communication between technical transfer internal and external team
    • Support technology transfer activities as a primary duties
    • Implement and maintain high standard of quality and regulatory compliance to meet and exceed regulatory agency and quality requirements
    Online since: Mon Aug 26 14:29:30 CEST 2024
    Reference number: 780419/1

    Scientist Immunology and Cardiovascular/Metabolic Disease (LSW) - BS (m/f/d)

    Freelance/temporary employment for a project
    Basel Stadt
    • Carefully design, organize, and manage externally run studies in collaboration with internal scientists, procurement and contract research organizations in a timely manner
    • Act as an advisor for study design: Define scientific rationale, success metrics and monitor progress
    • Provide high quality analysis of conducted studies and summarize, present and discuss study results with project teams
    • Ensure excellent interaction with vendors and maintain overview on activities and capabilities of relevant CROs
    • Work on a flexible schedule to meet deadlines
    Online since: Tue Aug 27 11:29:41 CEST 2024
    Reference number: 793457/1

    Scientist Analytical Chemistry (m/f/d)

    Freelance/temporary employment for a project
    Basel Stadt
    • Plan, interpret and report results of scientific experiments for timely supply of drug substances (DS) and drug products (DP)
    • Write & review analytical documents (e.g Analytical methods, Specifications, Validation reports, Stability reports, Batch records for stability and release testing) and align the corresponding activities within a global project team
    • Manage interactions with internal and external stakeholders, including outsourced activities to CROs by providing scientific and technical guidance whenever necessary
    • Proactively identify scientific, technological and GMP challenges, propose creative solutions and communicate key issues to the Analytical Project Leader or respective technical project team
    • Work according to appropriate SOPs, GMP, Quality Directives, Health and Safety & internal Company guidelines
    • Provide valuable input to the analytical CMC documents and support regulatory submissions
    • Drive, lead, and manage analytical activities including impurity profiling related to the analytical development of RLTs compounds (e. g. method development, validation, stability, and release testing)
    • Provide scientific guidance to the cross-functional and global project teams and thereby scientifically driving our exciting RLT portfolio
    • Display a collaborative and inspired attitude within project teams and our stakeholders and partners is key.
    Online since: Thu Nov 14 12:12:19 CET 2024
    Reference number: 779339/1

    Senior Scientist Validation (m/f/d)

    Freelance/temporary employment for a project
    Neuchatel
    • Develop, implement and manage the site process validation, and revalidation strategies to meet cGMP and quality requirements on time and on budget to ensure that programs are compliant with Regulatory Authorities’ expectations and related SOPs
    • Collaborate with cross functional teams to define the interfaces to equipment qualification / utilities qualification, system qualification and analytical method validation.
    • Establish and maintain the Validation Master Plan for process validation. Ensure that all manufacturing processes are validated, overview on state of validation at site is maintained.
    • Participate in transfers and launches, liaise with technical development for new products and align on the product validation approach. Contribute to provide experimental data obtained during the validation activities, which will be used to prepare the related registration documentation
    • Author or reviewer for routine validation protocols and reports, associated change controls and supports the execution at the shop floor
    • Develop the strategy for continued process verification that ensures all critical process parameters and quality attributes are monitored or analysed, and actions are defined and taken in case of trends or deviations. Reviews plans for CPV
    • Lead and drive investigation for validation related matters and implement corrective and preventive actions
    • Contribute to all relevant audit inspection and ensure inspection readiness for the site. Ensure compliance with relevant regulatory requirement, GMP, and other industry standards
    • Initiate, drive and implement continuous improvement initiatives to optimize processes, enhance produce performance and drive operational excellence for better quality, safety and efficiency
    Online since: Wed Aug 21 16:05:05 CEST 2024
    Reference number: 786664/1

    Development Engineer Manufacturing Processes (m/f/d)

    Freelance/temporary employment for a project
    Rotkreuz
    • Working in an interdisciplinary team of engineers to develop and improve manufacturing processes (including method evaluation and process control) for thick film sensors
    • Collection, analysis, and assessment of production and process control data and complement with additional analytical measurements
    • Support and run experimental studies for the sensor and process development, including planning, coordination, hands-on execution, and reporting of results
    • Contribute to the definition and documentation of the manufacturing processes and process control measures (e.g. pFMEA, flowcharts, manufacturing and test specifications)
    • Support the project team to ensure project deliverables, quality, and timeline
    Online since: Mon Oct 07 12:26:27 CEST 2024
    Reference number: 787497/1

    Data Scientist mit Laboraffinität (m/w/d)

    Anstellung bei der Hays Professional Solutions GmbH
    München
    • Auswertung von Daten mit Software und Data-Science-Tools
    • Planung, Durchführung und Evaluierung von Experimenten mit LC/MS-Systemen
    • Treffen mit internen und externen SW-Entwicklern durchführen, um die Entwicklung neuer SW-Tools gemäß den geplanten Zielen sicherzustellen
    Online since: Tue Nov 19 10:25:43 CET 2024

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    Reference number: 793815/1

    Senior Data Scientist (m/w/d)

    Anstellung bei der Hays Professional Solutions GmbH
    Gütersloh
    • Wie bereite ich mein Dataset vor (Preprocessing, Transformation, Aggregation, Balancing, Fitting, usw.)?
    • Wie wähle ich das passende Modell aus?
    • Was ist die beste Architektur des Modells (wie viele Layer und welche Layerart / - anordnung bei Deep Learning)?
    • Wie kann ich overfitting erkennen und verhindern?
    • Wie kann ich Biases erkennen und verhindern?
    • Wie kann ich am effektivsten meine Hyperparameter tunen?
    • Welche statistischen Analysen sind für mein Modell am sinnvollsten, um das Ergebnis zu evaluieren?
    Online since: Fri Nov 15 16:02:16 CET 2024
    Reference number: 779427/1

    Data Engineer (m/w/d)

    Festanstellung durch unseren Kunden
    Hameln
    • Datenmanagement und -analyse: Beschaffung, Aufarbeitung, Strukturierung und Analyse großer Datensätze
    • Modellierung: Entwicklung und Validierung von Machine Learning Modellen, insbesondere neuronaler Netze
    • Cloud-Technologien: Implementierung und Nutzung von Microsoft Azure
    • Systemwartung und Data Pipelines: Wartung bestehender Systeme und Entwicklung effizienter Data Pipelines
    • Ergebnispräsentationen: Erstellung ansprechender Präsentationen für Schulungs- und Informationszwecke
    • Datenbankadministration: Verwaltung von Datenbanken (Java, SQL, NoSQL)
    • Forschung & Entwicklung: Zusammenarbeit zur kontinuierlichen Produktverbesserung
    Online since: Thu Sep 26 16:42:56 CEST 2024
    Reference number: 767721/1

    Scientist (m/w/d)

    Anstellung bei der Hays Professional Solutions GmbH
    Marburg
    • Planung, und Durchführung von Virusvalidierungsstudien und Entwicklung von virusinaktivierenden und virusentfernenden Verfahrensschritten in Herstellungsprozessen von biopharmazeutischen Produkten
    • Eigenständige Entwicklung experimenteller Studiendesigns in Absprache mit dem Betreuer
    • Autorenschaft/Überprüfung von (GLP) Studiendokumentationen (Protokolle, Berichte)
    • Planung und Durchführung experimenteller Arbeiten einschließlich Datenanalyse und Kommunikation der Ergebnisse an Manager oder Projektteam in Form eines Berichts oder einer Präsentation
    • Durchführung von Virustitrationen zur Bestimmung von Virustitern unter L2/S2- (und L3/S3) Bedingungen
    • Durchführung diverser Analysenmethoden (Proteinbestimmungen, pH-Messungen, etc.)
    • Bedienung komplexer Geräte und Verarbeitung/Aufbereitung von Rohdaten
    • Sammlung, Aufbereitung und Verteilung von Proben/Daten in Abstimmung mit anderen Abteilungen und Teilnahme an lokalen und globalen Projekten
    • Erstellung und Pflege von Aufzeichnungen innerhalb interner Dokumentationssysteme
    • Erstellung und Überarbeitung von technischen Dokumenten, einschließlich Betriebsanweisungen, Test- oder Prozessprotokollen und Berichten
    • Unterstützung bei der Beschaffung neuer Geräte und Systeme 
    • Wartung von Laborgeräten nach spezifischen Qualitätsstandards (z.B. GLP)
    • Koordination der Verfügbarkeit von Materialien, Lösungen und Reagenzien
    Online since: Thu Sep 05 10:47:24 CEST 2024
    Reference number: 777745/1

    Junior Information Scientist (m/w/d)

    Anstellung bei der Hays Professional Solutions GmbH
    Großraum Ulm
    • Sie arbeiten in internationalen, interdisziplinären Projektteams auf die gemeinsame Zielerreichung hin und schlüpfen in die verantwortungsvolle Rolle als Teilprojektleiter
    • Sie sind verantwortlich für die Betreuung und Weiterentwicklung komplexer IT-Systeme im (non-) GMP-Umfeld
    • Sie kümmern sich um die Fehleranalyse, Systemanpassungen, die Durchführung von Funktionstests und die anschließende Dokumentation
    • Sie sind für die Evaluierung und Etablierung neuer innovativer IT-Lösungen in enger Zusammenarbeit mit den Anwendern der Abteilung „Pharmazeutische Entwicklung“ zuständig
    • Sie fungieren als Bindeglied zwischen der Fachabteilung, den IT-Experten und externen Partnern
    • Sie unterstützen die Wissenschaftler bei der Analyse komplexer Daten
    Online since: Fri Aug 09 14:30:20 CEST 2024
    Reference number: 793326/1

    Plattform Engineer (m/w/d)

    Freiberuflich für ein Projekt
    Frankfurt und Remote
    • Implementierung, Betrieb und Verbesserung von CI/CD-Pipelines mithilfe von Tools wie Azure DevOps oder GitLab CI/CD zur effizienten und automatisierten Softwarebereitstellung
    • Aufbau von Containern und deren Betrieb in Azure Kubernetes (gerne Fokus hier) um die Lauffähigkeit von KI-Anwendungen sicherzustelle
    • Nutzung von Infrastructure-as-a-Code (IAC)-Tools wie Terraform für die Infrastrukturaufbereitung und -konfiguration
    • Abstimmung mit Architekt, Data Scientist und Machine Learning Engineers zur Entwicklung, Deployment und Betrieb von KI Use Cases und der Weiterentwicklung der KI-Plattform
    • Monitoring und Incidentbehandlung in der Cloud-Infrastruktur der KI-Plattform
    • Mentoring und Support für Engineers in DevOps Best Practices
    Online since: Fri Nov 15 14:25:07 CET 2024

     

     

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