Position Title: Scientist III
Location: Lake County, IL (100% Onsite)
Pay Rate: $55–$59/hr.
Duration: 1 Year Contract
Job Description
Seeking a Scientist III to support biologics drug product formulation and process development across multiple biologics projects. The role focuses on formulation development, protein characterization, sterile manufacturing process development, scale-up, and technology transfer.
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.
Education
- Bachelor's, Master's, or PhD in Pharmaceutics, Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related scientific discipline.
- Industry experience requirements:
- Bachelor's: 8+ years
- Master's: 6+ years
- PhD: Recent/0-4 years
Required Skills
- 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.
- Design of Experiments (DoE).
- Multivariate statistical analysis and data visualization.
- cGMP and regulatory guidance.
Preferred Skills
- Biologics drug product control strategies.
- Quality risk management.
- Formulation robustness studies.
- Experience supporting internal and external manufacturing technology transfers.
- Experience with biologics including proteins, conjugates, and peptides.
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