What You Will Do
- Lead an innovative research project focused on enabling high concentration biologic drug products through particle engineering and suspension based formulation and fill/finish approaches.
- Design and execute studies for high concentration protein formulations by evaluating viscosity reducing excipients and formulation strategies.
- Execute and document laboratory studies (e.g., UF/DF, spray drying, mixing, stability).
- Evaluate product/process performance via analytical testing (e.g., SEC, CEX-U/HPLC, particle analysis, moisture content).
- Apply solid-state methods (SEM, DSC, DVS) to relate formulation composition, particle structure, stability, and product performance.
- Perform rheological characterization of high concentration formulations and suspensions.
- Develop/evaluate concentrated protein suspension formulations for parenteral delivery, including device compatibility.
- Build data/analytics solutions using tools such as TIBCO Spotfire and MS Smartsheet.
- Perform statistical data analysis (e.g., JMP, SAS).
- Author/review/data-verify technical protocols and reports; share results and challenges in team meetings.
- Adapt to flexible working hours; work effectively across time zones.
What We Expect Of You
Basic Qualifications:
- PhD at time of appointment
Preferred Qualifications/Skills:
- Process development experience; knowledge of drug product unit operations (UF/DF, filling, filtration, mixing) and analytical techniques (SEC, CEX, HIAC, MFI).
- Experience developing spray dried particles/microparticles and understanding protein physical/chemical stability.
- Experience with concentrated protein suspension formulations for prefilled syringes (device compatibility, break-loose force, extrusion force, injectability, dose delivery).
- Proficiency in statistical software (SAS/JMP/Minitab).
- Experience with programming (Python/R/MATLAB), SQL, data analytics/modeling, and visualization tools (Tableau/Spotfire/D3js).
- Self-motivation, adaptability, critical thinking, independent research, strong organization and attention to detail, and excellent oral/written communication.