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BioAgilytix Boston, 1320 Soldiers Field Road, Boston, MA, USA ● Req #62Friday, November 4, 2022Our clients trust us to deliver excellence in data and bioanalysis and in this role and you will be a critical part of our beginning-to-end client data quality processes. Through your technical reviews of raw and processed data, you will ensure data integrity standards are met across various equipment, regulatory settings, and workflows. You are the bridge between the lab and the quality assurance team, combining observations on regulatory requirements with your knowledge of plate-based assays ...Read more about Data Reviewer (QC)More
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BioAgilytix Boston, 1320 Soldiers Field Road, Boston, MA, USA ● Req #70Friday, November 4, 2022In this role, you will champion quality and compliance in our solutions. Our clients trust us to deliver excellence in data and bioanalysis, and this role is the last destination before our data is delivered. You will ensure standard methods and protocol requirements are met through thorough monitoring and audits. Partnering with the Operations team, you will review key procedures in a GxP environment, highlight any gaps or deviations in approach, then advise on corrective action, which leads us ...Read more about Senior QA AuditorMore
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BioAgilytix Boston, 1320 Soldiers Field Road, Boston, MA, USA ● Req #96Friday, November 4, 2022In this role, you will lead the development and validation of molecular assays to bring novel gene and cell therapies to market. This role is never boring due to our wide variety of clients and broad ranges of medicine treating different types of diseases. You’ll work in a milestone driven environment generating data, evaluating the performance of the medicine and context of use. Data integrity and quality are important to us, and this role will integrate the expectations in a highly regulated s ...Read more about Scientist (Gene and Cell Therapy)More
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BioAgilytix Boston, 1320 Soldiers Field Road, Boston, MA, USA ● Req #66Friday, November 4, 2022Essential Responsibilities Develop and validate biomarker, cell-based, immunogenicity, immuno- and enzymatic assays for support of preclinical, clinical and product release studies Work closely with clients to assure successful on time execution of assays, validation and sample analysis under GxPs Design and execute experiments efficiently Conduct routine analysis Present data and posters Perform statistical analysis Write reports and prepare SOPs ...Read more about Principal Investigator (PI)More
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BioAgilytix Labs, 2300 Englert Drive, Durham, NC, USA ● Req #252Thursday, November 3, 2022In this role, you will partner with our Principal Investigators or Bioanalytical Project Managers (BPMs) to manage every stage of our projects, from start to finish. The Study Coordinator role is the foundation for managing client projects and scientific execution in an efficient manner. You’ll experience a broad range of responsibilities, spanning study administration, data management and client communications. We are looking for candidates who get energized by complicated bioanalytic challenge ...Read more about Study CoordinatorMore
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BioAgilytix Labs, 2300 Englert Drive, Durham, NC, USA ● Req #251Wednesday, November 2, 2022In this role, you will perform validation studies through the analysis of biological samples. Our clients trust us to deliver excellence in data and bioanalysis, and this role is a bedrock within our project lifecycle. You will work on a wide variety of sample validations, including biologics, protein, peptides, small molecules, and/or biomarkers with a team of expert scientists. This role is also exposed to a range of analytical instrumentation and each project looks different than the previous ...Read more about AnalystMore
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BioAgilytix Europe GmbH, Lademannbogen 10, Hamburg, DE-HH, DEU ● Req #249Thursday, October 6, 2022Ihre Aufgabengebiete: Schnittstellenfunktion zwischen Labor, Kunden und Lieferanten Eigenständige Verwaltung von Proben aus präklinischen und klinischen Studienproben Empfang von Studienproben, manuell oder mit einer elektronischen Datenbank (Watson-LIMS) Verteilung von Studienproben an Analysten für Probenanalysen Selbständige Durchführung und Dokumentation von Bestandänderungen, Entsorgung, Rücksendung von Studienproben Verwalten der Wats ...Read more about Mitarbeiter für die Probenverwaltung und -Logistik (m/f/d) in VollzeitMore
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BioAgilytix Europe GmbH, Lademannbogen 10, Hamburg, DE-HH, DEU ● Req #110Thursday, October 6, 2022Ihre Aufgabengebiete: Selbständige Planung, Durchführung und Auswertung immunologischer Testverfahren im Labor (z. B. ECL, ELISA, zell-basierte Assays) Akkurate Dokumentation von Versuchsplanung und Ergebnissen nach GxP Planung und Durchführung von Validierungen und Probenanalysen als leitender Analyst Selbständige Planung und Durchführung von Assay-Entwicklungsprojekten Erstellen von technischen Standardarbeitsanweisungen (SOPs) Unterstütz ...Read more about Scientist (m/f/d) in VollzeitMore
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BioAgilytix Labs, 2300 Englert Drive, Durham, NC, USA ● Req #236Wednesday, September 14, 2022You will manage numerous workstreams to deliver against project objectives successfully and in a timely manner. Essential Responsibilities Responsible for authoring Project Plans, Project Charters, Statements of Work, Resource Plans, Risk Assessments, and Testing Plans for a variety of enterprise-level, global projects including on-prem and cloud-based software solutions Responsible for driving internal stakeholders and delivering on project objectives. Responsible for monthly budget recon ...Read more about Associate Manager, Enterprise PlanningMore
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BioAgilytix Europe GmbH, Lademannbogen 10, Hamburg, DE-HH, DEU ● Req #222Tuesday, August 23, 2022Responsibilities:Support maintaining projects’ schedule and resource management Track and facilitate project deliverables, ensure meeting timelines. Ensure proper coordination with group functions such as Operations, QA, QC, Finance and BD Report the progress of projects on regular base Report and improve operation’s metrics, evaluations, and assessment of results Proactive involvement and improvement of processes occurring during the project’s lifetime Provide sustainable data to st ...Read more about Associate Project Manager for Project Management OfficeMore
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BioAgilytix Europe GmbH, Lademannbogen 10, Hamburg, DE-HH, DEU ● Req #213Tuesday, July 26, 2022Ihre Aufgabengebiete: Planung, eigenständige Durchführung und initiale Auswertung immunologischer Testverfahren im Labor (z. B. ECL, ELISA, zell-basierte Assays) Allgemeine Laborarbeiten Akkurate Dokumentation von Versuchsplanung und Ergebnissen nach GxPBeteiligung als Analyst in verschiedenen regulierten Studienphasen (Validierung, Probenanalyse nach GLP/GCP) Erstellen von technischen Standardarbeitsanweisungen (SOPs) Beteiligung am Troubleshooting von Assays Ansetzen von Puffern, R ...Read more about Laborant (m/f/d) in VollzeitMore
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BioAgilytix Europe GmbH, Lademannbogen 10, Hamburg, DE-HH, DEU ● Req #201Tuesday, July 5, 2022Hervorragende Wissenschaft erfordert großartige Mitarbeiter. Bei BioAgilytix als Mitarbeiter des Qualitätsmanagement (m/f/d) in Vollzeit, bestehen die Aufgaben darin, als interner Quality Assurance Auditor (m/f/d) die Abteilung Qualitätssicherung zu unterstützen. Sie haben eine naturwissenschaftliche Ausbildung oder Studium und suchen eine unbefristete Anstellung? Bei uns erwarten Sie folgende Verantwortlichkeiten: Ihre Aufgabengebiete:Durchführung von internen Plan-, Daten-, Berichts- und Stu ...Read more about Mitarbeiter Qualitätsmanagement (m/f/d) in VollzeitMore
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BioAgilytix Europe GmbH, Lademannbogen 10, Hamburg, DE-HH, DEU ● Req #200Monday, July 4, 2022Für eine Reihe klinischer Projekte suchen wir einen Analysten (m/f/d), BTA (m/f/d), MTA (m/f/d) in Vollzeit zur tatkräftigen Unterstützung für die routinemäßige Aufreinigung und Kryopräservierung von Immunzellen aus Blutproben. Ihre Aufgabengebiete: Eigenständige Durchführung der Probenisolation mittels Gradientenzentrifugation im Labor Dokumentation der Ergebnisse sowie Lagerung und Inventarisierung der Proben nach GxPBereitstellung der Proben für den Versand Erstellen von technischen S ...Read more about Analyst (m/f/d) in VollzeitMore
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BioAgilytix Europe GmbH, Lademannbogen 10, Hamburg, DE-HH, DEU ● Req #180Tuesday, June 14, 2022Ihre AufgabengebietePriorisierte Bearbeitung von Benutzeranfragen in einem IT-Ticket-System, unter Einbindung anderer Supportressourcen nach Bedarf Befolgen von standardisierten Betriebsverfahren, einschließlich derjenigen für Accountverwaltung, Arbeitsplatzkonfiguration, Änderungskontrolle, Anwendungskonfiguration und Problembehebung Inventarisierung technischer Vermögenswerte, zur Ermittlung von aktuellem und zukünftigem Bedarf Erstellen und Verwalten von Betriebssystem-Images Audiovis ...Read more about IT-Support Specialist (m/f/d) in VollzeitMore
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BioAgilytix Europe GmbH, Lademannbogen 10, Hamburg, DE-HH, DEU ● Req #163Thursday, March 24, 2022At BioAgilytix, you will be part of a highly professional team that supports cutting-edge bioanalytical methods with world-class biopharmaceutical services. Responsibilities: Provide scientific and operational leadership to bioanalytical working groups, including overseeing the development and validation of new testing procedures and analysis of patient samples Lead, manage and develop a team of Principle Investigator and bioanalytical working groups Make sure ...Read more about Director (Senior) Operations (m/f/d) (full time) in HamburgMore
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BioAgilytix Europe GmbH, Lademannbogen 10, Hamburg, DE-HH, DEU ● Req #126Tuesday, December 21, 2021Ihre Aufgaben: Die Hauptaufgaben dieser unbefristeten Stelle bestehen darin, umfassende Unterstützung in der Qualitätssicherung zu bieten. Die Position erfordert, die Mitarbeit bei der Entwicklung, Verbesserung und Umsetzung des Qualitätsmanagementsystems. Der Mitarbeiter berichtet an den Director of Quality Assurance mit folgenden Verantwortlichkeiten: Durchführung und Überwachung der Gerätequalifizierungs- und Computervalidierungsaktivitäten Erstellen, Überarbeiten u ...Read more about QA Engineer (m/f/d) in VollzeitMore
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BioAgilytix Europe GmbH, Lademannbogen 10, Hamburg, DE-HH, DEU ● Req #112Friday, November 12, 2021Essential Responsibilities: Establish and maintain GMP related processes within Bioanalytical Operations on the regulatory aspects and support the scientific team on practical aspects Develop and validate/supervise potency bioassays biomarker, cell-based, immunogenicity, immuno- and assays for support of preclinical, clinical and product release studies Conduct/supervise routine sample analysis in GxP regulated environments Fulfills the role of responsible p ...Read more about Associate Principal Investigator / Principal Investigator GMP Regulations (m/f/d) (full time)More
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BioAgilytix Europe GmbH, Lademannbogen 10, Hamburg, DE-HH, DEU ● Req #111Friday, November 12, 2021Essential Responsibilities: Develop and validate/supervise biomarker, cell-based, immunogenicity, immuno- and enzymatic assays for support of preclinical, clinical and product release studies Conduct/supervise routine sample analysis in GxP regulated environments Fulfills the role of responsible project leader / analytical project manager for multiple projects Full scientific responsibility for the assigned projects Write plans/reports for method va ...Read more about Associate Principal Investigator / Principal InvestigatorMore