Scientist – Drug Product Development

This is primarily a Biologics Pharmaceutical Development / Drug Product Development Scientist role with a strong emphasis on analytical characterization and LC-based techniques, especially LC and iCIEF.

Job Description

1. Support laboratory-based biologics drug product and pharmaceutical development activities from early development through clinical manufacturing.
2. Execute formulation, drug product process development, and physicochemical characterization studies for therapeutic biologics.
3. Perform hands-on analytical testing using HPLC/UPLC and LC-based techniques.
4. Required experience with LC and iCIEF (imaged capillary isoelectric focusing) for biologic characterization.
5. Perform chromatographic analysis including SEC, RP, HIC, IEX/CEX, and preferably CAD detection.
6. Conduct charge variant analysis, CE-SDS, particle analysis, and other protein characterization assays.
7. Prepare samples, standards, buffers, solvents, and solutions using accurate calculations and laboratory procedures.
8. Operate, maintain, calibrate, and troubleshoot analytical laboratory instruments and equipment.
9. Execute assigned experiments independently and support the planning of smaller formulation or drug product studies.
10. Analyze experimental data, identify trends, investigate atypical results, and develop scientifically supported conclusions.
11. Recommend appropriate next steps based on experimental findings and escalate complex technical issues when necessary.
12. Contribute to analytical method development, optimization, qualification, and troubleshooting activities.
13. Support formulation development and optimization of biological drug products, including protein-based therapeutics.
14. Apply knowledge of protein chemistry, biochemical properties, stability, aggregation, purity, and charge heterogeneity.
15. Maintain accurate laboratory notebooks and records in accordance with GDP, GxP, and laboratory safety requirements.
16. Prepare study plans, technical reports, SOPs, technical memos, and other scientific documentation.
17. Collaborate with Analytical Development, Quality, Manufacturing, R&D, Process Development, and Project Management teams.
18. Support technology transfer, scale-up, clinical manufacturing, and clinical material production activities.
19. Demonstrate understanding of aseptic processing and sterile fill-finish principles for parenteral biologics.
20. Manage multiple projects in a fast-paced environment while communicating results, risks, timelines, and recommendations effectively.