Associate Principal Investigator / Principal Investigator
Hamburg
Lab Operations /
FT /
On-site
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.
Essential 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 validations and sample analysis
- Act as single point of contact for customers
- Meet client expectations/timelines
- Ensure deliverables are accurate and on-time
- Present data to clients
- Serve in a supervisor role and leading teams in a limited capacity
- Apply knowledge of regulatory guidance to experimental planning and design
- Responsible for budget achievement of the group
- Familiar with the quote/contract and communicate with sales team and/ or clients accordingly
- Communication with the sales team regarding proposal, timeline, and / or other project related issues, report to line manager when any issues are identified
- Support the sales team with preparation and presentation of proposals in terms of science/technology
- Present data in conferences, presentations, reports and posters
- Participate in audits and customer visits
Skills:
- Bachelor’s degree in molecular biology, biochemistry, immunology, biotechnology, or related field with > 8 years’ experience in a regulated laboratory environment; or
- Master’s degree in molecular biology, biochemistry, immunology, biotechnology, or related field with > 6 years’ experience in a regulated laboratory environment; or
- PhD in molecular biology, biochemistry, immunology, biotechnology, or related field 0-2 years’ experience in a scientific laboratory environment
- Experience in leading a team, bioanalytical operations, and product/project management in the pharmaceutical/biotechnology industry, 2+ years’ internal Associate Principal Investigator experience, with exceptions
- Ability to develop bioanalytical and/or immunoassays in some or all of the following immunoassay platforms: ELISA, MSD-ECL, Phadia, GyroLab, ELISPOT, SPR, PCR
- knowledge and experience of GxP regulations and guidelines preferred
- Understanding and experience with assay development and GCP, GLP and/or GMP procedures is preferred
- experience with software PLA and LIMS preferred
- Must work effectively within team to meet objectives under time constraints
- Ability to take direction well and multi-task
- Detail oriented and highly organized
- Excellent oral and written communication skills
- Proficient in the use of MS Office programs
- Demonstrated experience serving in a supervisor role and leading teams
- Fluency in English is required as well as in German
Personnel responsibility for up to 4 employees
- Analysts, Senior Analysts, Scientists
Place of work:
- Laboratory / Office in Hamburg, Germany
- Occasional weekend, holiday, and evening work required
- Occasional travel
Was wir dir 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
