Senior Scientist, Formulation Science
On-siteDurham, North Carolina, United States
Job Summary
Lead pre-formulation and formulation development for protein biologic therapeutics, including excipient screening, optimization, and stability studies. Qualify and interface with external partners to screen, identify, and supply prefilled syringe, autoinjector, and on-body delivery systems. Characterize formulation performance using biophysical and analytical methods to assess aggregation, thermal stability, and particulate risk. Author technical reports supporting manufacturing readiness, process transfer, and CMC regulatory filings. Mentor colleagues in GxP practices and collaborate with cross-disciplinary teams across development stages.
Required Qualifications
- Device and combination product experience
- Hands-on selecting and advancing a delivery system for a biologic
- Regulatory work to take it into the clinic
- Ph.D. in Chemical Engineering, Biochemical Engineering, Pharmaceutical Sciences, Biological Sciences, or a related discipline with at least 1-3 years of formulation development experience in the pharmaceutical or biotechnology industry, preferably with biopharmaceutical products
- B.S. or M.S. in Chemical Engineering, Biochemical Engineering, Pharmaceutical Sciences, Biological Sciences, or a related discipline with at least 5-8 years of formulation development experience in the pharmaceutical or biotechnology industry, preferably with biopharmaceutical products
- Demonstrated experience developing formulations for protein therapeutics, including high concentration liquid presentations
- Knowledge of forced degradation study design, stability protocol development, and interpretation of formulation-relevant stability data
- Broad experience with analytical and biophysical instrumentation used in formulation development, such as spectrophotometers, DLS, DSC, FTIR, viscometers, particle counters, and other tools used to assess formulation stability and drug product performance
- Experience in authoring technical reports
- Demonstrated ability to bring in new technology and processes to improve formulation development
- Experience using data analysis and statistical tools such as JMP or Minitab, including application of design of experiments approaches to formulation development
- Understanding of relevant ICH, USP, Ph. Eur., FDA, and other applicable regulatory expectations for biopharmaceutical drug product development
- Detailed knowledge of sterile fill-finish operations and scale-up, with the ability to lead development and transfer of fill-finish activities
- Demonstrated ability to work collaboratively in a laboratory environment
- Experience contributing to CMC regulatory documents, including technical summaries, justifications, and responses to regulatory questions
- Demonstrated knowledge of primary packaging materials used for sterile dosage forms, including considerations for compatibility, extractables and leachables, and container closure integrity
- Ability to collaborate with and lead cross-disciplinary teams across multiple therapeutic areas and development stages
Desired Qualifications
- Experience developing high-concentration biologic formulations and evaluating viscosity, particulate formation, syringeability, injectability, and dose compatibility
- Experience maintaining, troubleshooting, and qualifying formulation-related laboratory equipment
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