Director (Senior) Operations (m/f/d) (full time)

Einsatzort: Hamburg

BioAgilytix ist ein führendes bioanalytisches Auftragsforschungsinstitut (CRO) für die Zulassung von Biopharmazeutika. Unsere umfassenden Labordienstleistungen unterstützen jede Phase der Zulassungsstudien - von frühen Entwicklungsarbeiten über präklinische Analysen bis hin zu klinischen Phasen unter GxP Regularien. Unser globales Team von Experten in Europa (Hamburg) und USA (Durham, San Diego und Boston) unterstützt mit großem Engagement und Begeisterung forschende Pharma- und Biotech-Unternehmen bei der Zulassung neuartiger Medikamente, damit Patienten möglichst schnell und effektiv davon profitieren. Hervorragende Wissenschaft erfordert großartige Mitarbeiter. Bei BioAgilytix werden Sie Teil eines hochprofessionellen Teams, das modernste bioanalytische Methoden mit erstklassigen Dienstleistungen für Biopharmazeutika unterstützt.

At BioAgilytix, you will be part of a highly professional team that supports cutting-edge bioanalytical methods with world-class biopharmaceutical services.Director (Senior) Operations (m/f/d) (full time)

Director (Senior) Operations (m/f/d) (full time)


BioAgilytix Europe GmbH, Lademannbogen 10, Hamburg, Deutschland Erf #163

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 compliance with legal requirements as well as compliance with guidelines in the operation of the testing facility, i.e. the bioanalytical laboratory
  • Ensuring reliable resource planning, project progress and completion as well as budget achievement
  • Support Business Development providing scientific guidance for new contracts
  • Closed interaction with QA department to ensure timely project deliverables
  • Closed alignment and communication with customers to achieve project deliverables in alignment with regulatory and client's expectations
  • Improve and optimize the operational processes including lab automation and data management.
  • Monitoring of operations related key performance indicators

Education & Experience:

  • PhD in Life Science (molecular biology, biochemistry, immunology or related field) with broad bioanalytical background.
  • 5+ years' experience in preclinical and clinical assay development/ bioanalytical operations and in leading scientific teams or project management in the pharmaceutical/biotechnology industry or CRO environment is expected.
  • In-depth understanding of GLP, GCP / GCLP and/or GMP procedures.
  • Must have working knowledge of the FDA and EMEA guidelines and industry standards.
  • Fluency in English is required, fluency in German is desired.
  • Excellent oral and written communication skills and attention to detail.

Skills:

  • Demonstrated experience in bioanalytical assay development, validation and sample analysis
  • Extensive working knowledge of laboratory techniques in immunology, biochemistry and molecular biology
  • Creative problem-solving skills
  • Ability lead a team of Principle Investigators, Scientist and Analysts
  • Advanced experience in bioanalytical platforms (e.g. MSD-ECL, Phadia, ELISA, SPR, qPCR/ ddPCR, Gyrolab etc.)
  • High innovative ability for the development of new methods for bioanalytical research
  • Capability to work under pressure and tight deadlines in a fast-paced team environment

Was wir Ihnen bieten:

  • Unbefristetes Arbeitsverhältnis
  • Flexible Arbeitszeiten
  • Kollegiales Arbeiten in einem hochmotivierten Team
  • Strukturierte Einarbeitung (Onboarding, Mentoring und Einweisung)
  • Zuschuss zum ÖPNV Verbund / Profiticket und Firmenparkplätze
  • Beteiligung an der betrieblichen Altersvorsorge und/oder vermögenswirksamen Leistungen
  • Zusätzliche betriebliche Krankenversicherung
  • Team-Events
  • Corporate Benefits
  • Programm zur Mitarbeiterempfehlung
  • Gutes Betriebsklima in einem internationalen Umfeld
  • Freie Getränke und Obst

Treffen Sie uns auf der T5 JobMesse in Hamburg am 26. Oktober 2022