Jobid=e7db984c6040 (0.0986)
Scientist Biologics / Senior Scientist Biologics J&J
Location: Leiden, The Netherlands
Workload: 32-40 hours per week
Onsite requirement: Minimum 60% onsite
Travel: None
Experience: 4-6 years
Education: Bachelor's degree or equivalent
Department: Analytical Development – Biologics
Role Overview
We are seeking a highly skilled Scientist Biologics AD or Senior Scientist Biologics AD to join our Analytical Development team in Leiden. In this position, you will contribute to excipient method development and co‑validations in support of our protein-based biologics portfolio. You will act as a subject matter expert in chromatographic methods and play a key role in the development, validation, troubleshooting, and transfer of analytical methods.
Key Responsibilities
Analytical Expertise & Method Ownership
- Serve as commercial Subject Matter Expert (SME) for size-exclusion HPLC (SEC), ion‑exchange chromatography (IEX), and hydrophobic interaction chromatography (HIC) methods.
- Act as instrument owner for multiple HPLC systems, providing troubleshooting, maintenance coordination, and performance oversight.
- Contribute to the design, execution, optimization, and co‑validation of excipient and protein analytical methods.
Laboratory & Documentation Activities
- Plan, design, and execute laboratory experiments in accordance with project timelines and quality standards.
- Analyze data, draw conclusions, and prepare high-quality reports, protocols, and documentation.
- Support and conduct scientific investigations and root‑cause analyses related to method performance, development issues, tech transfer, or routine application.
Cross-Functional Collaboration
- Work effectively in multidisciplinary teams involving analytical development, manufacturing, quality assurance, quality control, and process development.
- Lead and participate in method validation strategy development.
- Contribute to regulatory submissions and support interactions with health authorities as needed.
Training & Technical Support
- Coordinate and deliver laboratory training for colleagues.
- Provide scientific guidance and mentor junior team members where required.
Must‑Have Qualifications
- Bachelor's degree (or equivalent) in Life Sciences, Chemistry, Biotechnology, or related field.
- 4-6 years of relevant industry experience, preferably within biologics analytical development or QC.
- Strong technical expertise in HPLC-based chromatographic methods (SEC, IEX, HIC).
- Demonstrated experience in method development, optimization, and validation.
- Hands-on troubleshooting experience with HPLC instruments.
- Ability to work independently as well as in a team environment.
- Excellent written and verbal communication skills, including scientific reporting.
Preferred Qualifications
- Experience supporting regulatory filings.
- Experience in technology transfer environments.
- Familiarity with excipient analysis or advanced protein characterization.
- Experience in GMP or GxP-regulated environments.
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