Analytical Scientist

Title: Sr. Scientist





Location: San Diego, CA





Duration: 6+ Months





Job Summary

We are seeking a highly motivated Sr. Scientist to join our Pharmaceutical Development team in supporting laboratory-based
biologics drug product development.

The successful candidate will execute assigned studies and, as experience permits, plan and lead smaller defined work items under general to broad supervision. This role will support laboratory instrument setup and capability, phase-appropriate formulation and drug product process development, and physicochemical/bioanalytical characterization using state-of-the-art analytical methods and equipment.





Key techniques include UPLC/HPLC, SEC, RP, HIC, IEX/CEX, CAD, charge variant analysis, particle analysis, and CE-SDS.
Hands-on experience with LC and iCIEF is required.





Key Responsibilities:


- Support the setup, operation, maintenance, and routine troubleshooting of laboratory instruments.
- Support analytical method development and draft procedures, reports, SOPs, and best-practice documentation.
- Independently execute assigned experiments and, with appropriate experience, plan or lead smaller studies supporting formulation and drug product process development.
- Analyze and interpret experimental data, identify trends or atypical results, and make scientifically supported conclusions and recommendations.
- Draft study plans, development reports, technical memos, and other scientific documentation.
- Perform physicochemical and bioanalytical characterization using established analytical instrumentation and techniques.
- Contribute to optimization and improvement of analytical methods as needed.
- Collaborate with project management, QA, analytical, R&D, non-clinical, manufacturing, and external partners.
- Support development activities, technology transfer, and clinical material production.
- Communicate study progress, timelines, results, risks, and recommendations clearly to project teams and management.
- Prepare samples, solvents, standards, buffers, and other solutions using accurate calculations, weighing, and documentation.
- Maintain laboratory notebooks, study documentation, inventory, and instrument maintenance schedules.
- Contribute to laboratory organization, process improvements, and guidance of less-experienced colleagues on established procedures.
- Follow laboratory safety requirements and Good Documentation Practices (GDP).
- Perform other duties as assigned.






Required Skills & Qualifications:


- Working to strong understanding of the biochemical and physical properties of therapeutic biologics, including proteins and other relevant modalities.
- Knowledge of commonly used protein quantification and characterization approaches.
- Relevant experience in formulation, drug product, analytical, or related biologics development.
- Hands-on experience with analytical instruments commonly used in a biologics drug product laboratory.
- Required: Hands-on experience with LC and iCIEF.






Experience with analytical techniques such as:


- UPLC/HPLC ,SEC
- RP
- HIC
- IEX/CEX
- CAD
- Charge variant analysis
- Particle analysis
- CE-SDS
- Ability to independently perform routine analytical testing and troubleshoot minor instrument or method issues.
- Ability to analyze results, recognize trends and atypical data, and make scientifically supported conclusions.
- Strong technical writing skills, including experience drafting SOPs, study plans, technical reports, technical memos, and best-practice documentation.
- Ability to perform basic to moderately complex formulation and drug product studies.
- Understanding of aseptic processing fundamentals and sterile fill-finish concepts for parenteral biological drug products.
- Working knowledge of GxP principles and compliance expectations for biological drug products preferred.
- Experience supporting pharmaceutical product development, process scale-up, technology transfer, or clinical manufacturing preferred.
- Demonstrated GDP and disciplined laboratory record keeping within a pharmaceutical or similarly regulated environment.
- Demonstrated ability and willingness to learn new scientific methods, tools, and techniques.
- Solid understanding of laboratory safety requirements and experience working safely in bioanalytical or pharmaceutical development laboratories.






Preferred Experience:


- Biologics drug product development
- Formulation development
- Analytical method development
- Physicochemical characterization
- Protein characterization
- Sterile fill-finish / aseptic processing
- Pharmaceutical product development and scale-up
- Technology transfer
- Clinical manufacturing
- GxP-regulated laboratory environments