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. Work with FDG leads and scientists to ensure robust process development, technology transfer to manufacturing sites, and provide technical support toward GMP manufacturing, validation campaigns, and post-launch activities.

Responsibilities

• Perform gap and risk assessment for drug product (e.g., manufacturing process, scale, contact parts) to inform requisite process development studies.
• Plan, design, and execute drug product process development studies for various biologics to ensure robust characterization of unit operations (freeze/thaw, lyophilization, mixing, filtration, filling, etc.) across multiple 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.
• Work closely with FDG leads/scientists to ensure seamless progression of multiple late-stage process-related activities.
• Prepare, review, and edit technical reports.
• Bring in new ideas from literature and present work at group, department, and cross-functional meetings to improve efficiencies (e.g., in-silico modeling, process analytics and related tools).
• Demonstrate strong problem-solving skills via critical thinking and effective communication.
• Manage process development equipment installation, operation, maintenance, calibration, and repairs.

Qualifications

• Required: BS degree in Biomedical or Chemical Engineering, Pharmaceutical Sciences, or related field with at least 10+ years of relevant industry experience or MS degree with 8+ years of relevant industry experience. Experience with drug product development and characterization (formulation and process) required. Experience with lyophilization desired. Hands-on experience with analytical instruments used for biologics (HPLC-based techniques such as icIEF, SEC, IEX), biophysical methods (DLS, DSC, UV-Vis), particle characterization (MFI, HIAC) required. 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.
• Preferred: Additional quantification methods (as noted) and broader experience with biologics; strong modeling or analytics experience beyond basics.

Skills

• Analytical instrumentation for biologics (HPLC variants, icIEF, SEC, IEX)
• Biophysical characterization (DLS, DSC, UV-Vis)
• Particle characterization (MFI, HIAC)
• Other quantification methods (ddPCR, ELLA, mass photometry)
• Statistical analysis and DOE (experience with JMP)
• Strong written and verbal communication; ability to present at groups and cross-functional meetings
• Independent work style with the ability to collaborate in a team environment

Education

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