As a Scientist, your day-to-day activities will include:
- 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.
These are skills needed to be successful:
- 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
Minimum Preferred Qualifications - Education/Experience:
- 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
- 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, GC
Minimum Preferred Qualifications - Education/Experience
The benefits of joining our team:
- 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
Skills Required
- Experience developing, validating, and executing chromatographic and mass spectrometric assays (LC/MS, LC/MS/MS)
- Expertise extracting analytes from complex biological matrices using protein precipitation, liquid-liquid, solid phase, immunoprecipitation or other extraction techniques
- Design, plan, execute experiments independently; troubleshoot assays; analyze and interpret data; prepare reports, summary tables, plans, and SOPs
- Maintain accurate laboratory records, worksheets, and raw data; set up and manage studies in LIMS with peer review
- Proficiency in both German and English
- Ability to work effectively within a team under time constraints; strong communication and customer service orientation
- Working knowledge of SCIEX 7500+ and SCIEX OS
- Experience working in a regulated environment and knowledge of GDP, GLP, GCLP, GCP
- Master's degree in molecular biology, biochemistry, immunology, biotechnology, or related field with approximately six years' laboratory experience
- Proficiency with software tools: MassLynx, XCalibur, Chromeleon, Watson LIMS, JMP, GraphPad Prism, Microsoft Word and Excel
- Advanced capabilities in data analysis, data visualization, and statistical analysis
What We Do
BioAgilytix is a leading global contract research organization focused on supporting pharmaceutical and biotech partners in all phases of drug development. With laboratory locations in North Carolina’s Research Triangle Park; Cambridge, Massachusetts; San Diego, California; Melbourne and Brisbane, Australia and Hamburg, Germany, BioAgilytix provides PK, immunogenicity, biomarkers, and cell-based assay services supporting the development and release testing of therapeutics across a number of industries and disease states. BioAgilytix offers assay development, validation, and sample analysis under non-GLP, GLP, and GCP, as well as GMP quality control testing (i.e., product release testing, stability testing, etc.) BioAgilytix also offers diagnostic testing services at its CLIA-certified, CAP-accredited Boston laboratory. BioAgilytix’s team of highly experienced scientific and QA professionals ensures high-quality science, data integrity and regulatory compliance through all phases of clinical development. BioAgilytix is a trusted partner to many top global pharmaceutical and biotech companies. For more information, visit www.bioagilytix.com.


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