Biologics Formulation Scientist – Scale-Up & Transfer

The Fountain Group; Deerfield (IL); On-site; USD 76,000 - 81,000; Full time

Job summary

The Fountain Group in Lake County, IL seeks a Scientist III to support biologics drug product formulation and process development across multiple projects. The role focuses on formulation development, protein characterization, sterile manufacturing processes, scale-up, and technology transfer.

Responsibilities include leading formulation and process development, DoE and statistical analysis, protein stability assessment, and development of drug product control strategies in a cGMP environment.

Qualifications

• Hands-on biologics drug product formulation development.
• Protein analytical and biophysical characterization.
• Solid-state characterization techniques.
• Protein degradation mechanisms and stabilization strategies.
• Sterile manufacturing process development: freeze-thaw, mixing, filtration, filling, and lyophilization.
• Formulation and process characterization, scale-up, and technology transfer.
• DoE and multivariate statistical analysis.

Responsibilities

• Lead biologics drug product formulation and process development, including characterization and robustness studies.
• Perform formulation optimization and evaluate protein stability, degradation mechanisms, and stabilization strategies.
• Conduct analytical, biophysical, and solid-state characterization of proteins.
• Develop and characterize sterile manufacturing unit operations, including freeze-thaw, mixing, filtration, filling, and lyophilization.
• Support manufacturing scale-up and technology transfer to internal and external manufacturing sites.
• Apply Design of Experiments (DoE) and statistical analysis to formulation and process development studies.
• Develop drug product control strategies and apply quality risk management principles.

Skills

Biologics formulation development

Protein analytical characterization

Biophysical characterization

Sterile manufacturing process dev

Scale-up and tech transfer

Design of Experiments (DoE)

Multivariate statistics & data viz

cGMP regulatory compliance

Education

Bachelor's, Master's or PhD in related field

Job description

The Fountain Group in Lake County, IL seeks a Scientist III to support biologics drug product formulation and process development across multiple projects. The role focuses on formulation development, protein characterization, sterile manufacturing processes, scale-up, and technology transfer.

Responsibilities include leading formulation and process development, DoE and statistical analysis, protein stability assessment, and development of drug product control strategies in a cGMP environment.