The Fountain Group is a national staffing firm and we are currently seeking a Process Development Scientist for a prominent client of ours. This position is in North Chicago, IL 60064.
Process Development Scientist – Injectable Drug Products (Biologics)
Overview
We are seeking a Process Development Scientist to support parenteral (injectable) drug product development, with a primary focus on biologics. This is a hands‑on, lab‑based role within Product Development Science & Technology (PDS&T), responsible for formulation development, process optimization, and scale‑up activities from clinical through commercial stages.
This position is ideal for candidates with strong injectable formulation experience, a process development mindset, and the ability to work cross‑functionally in a fast‑paced pharmaceutical environment.
Key Responsibilities
- Perform hands‑on laboratory work including compounding, filtration, filling, and tangential flow filtration (TFF)
- Design and execute small‑scale experiments to evaluate formulation and process conditions
- Assess stability under various conditions (pH, temperature, stress, freeze‑thaw, etc.)
- Analyze experimental data, draw conclusions, and document findings in an Electronic Lab Notebook (ELN)
- Collaborate cross‑functionally with analytical, CMC, and manufacturing/scale‑up teams
- Support process development and scale‑up from clinical to commercial stages
- Contribute to technical reports, presentations, and internal documentation
Required Qualifications
- Bachelor’s or Master’s degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a related field
- Experience with parenteral / injectable drug product development
- Hands‑on lab experience with formulation and process development (must have direct ownership)
- Proven ability to design experiments, analyze data, and interpret results independently
- Strong communication skills and ability to collaborate across teams
Preferred Qualifications
- Experience working with biologics (e.g., monoclonal antibodies, proteins)
- Lyophilization experience (highly preferred)
- Exposure to freeze‑thaw, mixing, filtration, and filling processes
- Familiarity with HPLC / chromatography techniques
- Experience with Design of Experiments (DOE) using tools such as JMP or Minitab
- Understanding of process scale‑up and technology transfer
Technical Skills
- Laboratory techniques: pH, osmolality, viscosity, density measurements
- Data analysis: Excel (required), JMP/Minitab (preferred)
- Documentation: ELN experience preferred
- Approximately 75% lab‑based / 25% data analysis and reporting
- Standard laboratory environment with PPE
- Limited remote flexibility for reporting tasks
Additional Information
- This role focuses on development‑scale work, not routine QC or manufacturing
- Relocation may be considered at the candidate’s expense
- Candidates with extensive experience (e.g., PhD + 5+ years) may be considered overqualified