At BioAgilytix, we are passionate about premier science and the impact it has on our world. Our team of highly experienced scientists and professionals deliver tailored services for supporting new medicine breakthroughs with best-in-class bioanalytical services. We are tirelessly committed to our customers by being solution-oriented and deadline-driven. . . and we are growing. Our culture is fast-paced, fun and never boring. Because we work across numerous clients and drug modalities, your career can develop rapidly. You’ll gain experience with a variety of challenges all while you enable life-changing, life-saving therapeutics to the patients who need them.
In this role, you will contribute to the development, optimization, and validation of LC/MS methods in a regulated environment, supporting both targeted and untargeted analyses using chromatography and mass spectrometric platforms. Working closely with a team of experienced bioanalytical scientists in both Hamburg and the U.S., you’ll help advance LC/MS capabilities while gaining exposure to complex analytical workflows that support drug development.
At our organization, we are committed to advancing analytical science to support innovation across the drug development lifecycle. This role offers the opportunity to contribute to impactful scientific work spanning drug discovery through clinical development, while collaborating in a highly technical, quality-focused environment dedicated to scientific excellence and continuous improvement.
- Independently lead assay development, validation, and sample analysis of various pharmaceuticals extracted from biological matrices including small molecules, biologics, proteins, peptides, ADCs, and/or biomarkers using chromatographic and mass spectrometric (LC/MS) techniques in support of preclinical, clinical, and product release studies.
- Design, plan, and execute experiments independently; troubleshoot assays; analyze and interpret data; prepare summary tables, plans, reports, and SOPs.
- Ensure regulatory compliance throughout assay development, validation, and sample analysis activities, including prompt identification and notification of deviations and preparation of associated documentation.
- Set up and manage studies in LIMS; maintain accurate laboratory records, worksheets, and raw data with peer review.
- Experience with development, validation and execution of chromatographic and mass spectrometric assays (LC/MS), and/or ability to perform most tasks associated with custom research planning and bench work
- Must work effectively within the team to meet objectives under time constraints
- Independence, enthusiasm, openness, and adaptability
- Demonstrated effective communication skills
- Working knowledge of SCIEX 7500+ and SCIEX OS preferred, with the ability to navigate instrumentation and interpret data outputs
- Demonstrated ability to contribute to the design and execution of efficient, impactful experiments
- Experience working in a regulated environment, with a thorough understating of GDP, GLP, GCLP, GCP is preferred
- The ability to inspire others to do their best work and drive results
- Strong customer service orientation with the ability to effectively support internal and external stakeholders
- Proficiency in both German and English is required
- Bachelor’s degree in molecular biology, biochemistry, immunology, biotechnology, or related field with not less than six (6) years’ experience in a scientific laboratory environment; or
- Master’s degree in molecular biology, biochemistry, immunology, biotechnology, or related field with not less than four (4) years’ experience in a scientific laboratory environment; or
- PhD in molecular biology, biochemistry, immunology, biotechnology, or related field with not less than two (2) years’ experience in a scientific laboratory environment
- Knowledge of regulatory guidance and industry best practices for LC/MS, and other large molecule assays
- Demonstrated expertise in developing chromatographic and mass spectrometric assays including LC/MS and LC/MS/MS for bioanalytical studies by extracting analytes of interest from complex biological matrices using protein precipitation, liquid-liquid, solid phase, immunoprecipitation or other extraction techniques
- Advanced capabilities in data analysis, data visualization statistical analysis
- Microsoft Word, Excel, SCIEX OS, MassLynx, XCalibur, Chromeleon, Watson LIMS, JMP, Graphpad Prism
- GDP, GLP, GCLP, GCP
- Bachelor’s degree in molecular biology, biochemistry, immunology, biotechnology, or related field with not less than eight (8) years’ experience in a scientific laboratory environment; or
- Master’s degree in molecular biology, biochemistry, immunology, biotechnology, or related field with not less than six (6) years’ experience in a scientific laboratory environment; or
- PhD in molecular biology, biochemistry, immunology, biotechnology, or related field with not less than four (4) years’ experience in a scientific laboratory environment
- Knowledge of regulatory guidance and industry best practices for LC/MS, and other large molecule assays
- Demonstrated expertise in developing chromatographic and mass spectrometric assays including LC/MS and LC/MS/MS for bioanalytical studies by extracting analytes of interest from complex biological matrices using protein precipitation, liquid-liquid, solid phase, immunoprecipitation or other extraction technique
- Advanced capabilities in data analysis, data visualization statistical analysis
- Microsoft Word, Excel, SCIEX OS, MassLynx, XCalibur, Chromeleon, Watson LIMS, JMP, Graphpad Prism
- GDP, GLP, GCLP, GCP
- Broad exposure to a wide variety of protein therapeutics (enzymes, gene & cell therapy, multifunctional therapeutic, oncolytic virus)
- Access to a network of expert bioanalytical scientists to collaborate with and grow
- Continued development and growth, international sites exposure and contacts
- Exposure to cutting-edge bioanalytical technologies
- Permanent employment
- Subsidy for the public transport network / professional ticket and company parking spaces
- Participation in company pension schemes and/or capital formation benefits
- Additional company health insurance
- Team events
- Corporate Benefits
We welcome all applications - regardless of gender, nationality, ethnic and social origin, marital status, religion/belief, disability, age, sexual orientation and identity. We do not tolerate racism or discrimination, because Diversity, Equity & Inclusion at BioAgilytix means "You belong"!
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.