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
- 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
- Analysts, Senior Analysts, Scientists
- Laboratory / Office in Hamburg, Germany
- Occasional weekend, holiday, and evening work required
- Occasional travel