Scientist - Formulation Process Development

Role Summary

Scientist to support drug product process development studies for biologics, including traditional monoclonal antibody (mAb) and non-traditional modalities. The candidate will work with FDG leads and scientists to ensure robust process development and technology transfer to manufacturing sites, and provide technical support towards GMP manufacturing, validation campaigns, and post-launch activities.

Responsibilities

• Perform gap and risk assessment for drug product to inform requisite process development studies.
• Plan, design, and execute drug product process development studies for various biologics to characterize unit operations across fill sites.
• Assist in developing small-scale models to mimic manufacturing unit operations and support technology transfer to manufacturing teams.
• Support in-house drug product toxicological lot manufacturing campaigns as needed.
• Collaborate with FDG leads/scientists to progress multiple late-stage process-related activities.
• Prepare, review, and edit technical reports.
• Bring in new ideas from literature and present work to improve efficiencies (e.g., in-silico modeling, process analytics/tools).
• Demonstrate proactive problem-solving skills through critical thinking and communication.
• Manage process development equipment installation, operation, maintenance, calibration, and repairs.

Qualifications

• BS in Biomedical or Chemical Engineering, Pharmaceutical Sciences, or related field with 10+ years of relevant industry experience, or MS with 8+ years of relevant industry experience.
• Experience with drug product development and characterization (formulation and process) required.
• Lyophilization experience desired.
• Hands-on experience with analytical instruments for biologics (HPLC-based: icIEF, SEC, IEX; biophysical: DLS, DSC, UV-Vis; particle characterization: MFI, HIAC).
• Other quantification methods (ddPCR, ELLA, mass photometry) preferred.
• Basic understanding of protein degradation pathways and biophysics.
• Experience with statistical software (JMP) for DOE and analyses preferred.

Skills

• Independence and ability to work within a team
• Multitasking and adaptability to changing priorities
• Initiative and drive to learn new technologies

Education

• BS or MS in Biomedical or Chemical Engineering, Pharmaceutical Sciences, or related field with relevant industry experience as noted above.