Biologics Formulation Intern

Role Description:

We are seeking a talented Biologics Formulations Summer Intern to join our team and contribute to the development of a robust moisture-prediction model for lyophilized drug products. In this role, you will support formulation development and data-driven research efforts aimed at improving the stability, quality, and performance of lyophilized pharmaceuticals.

Biologics Formulation Intern:Advancing Moisture Analytics: Development of a NIR Spectroscopy Method and Chemometric Model for Lyophilized Biopharmaceutical Products

Location: Kalamazoo, Michigan

Internship Summary:

This 10-12-week internship will focus on developing a rapid, non-destructive Near-Infrared (NIR) spectroscopy method to measure moisture content in lyophilized drug products as a Process Analytical Technology (PAT) tool. The intern will prepare samples across a range of moisture levels, collect paired Karl Fischer (KF) and NIR data, and develop and evaluate a chemometric model, such as partial least squares (PLS) regression. The project aims to enable faster, more efficient moisture analysis and support the future implementation of 100% vial testing and improved lyophilization process development.

Internship Job Duties:

· Familiarize and operate freeze-drying/lyophilization equipment and prepare formulations across a defined range of moisture-content targets.

· Perform Karl Fischer (KF) titration and acquire Near-Infrared (NIR) spectra using established sample-handling and laboratory procedures.

· Develop, optimize, and evaluate chemometric models-such as PLS regression-to correlate NIR spectra with KF moisture measurements.

· Process and analyze experimental data, assess model performance, and support method optimization to minimize false-positive and false-negative results.

· Conduct laboratory experiments under supervision, document findings, and contribute to technical reports and posters/presentations and analytical-method documentation supporting future PAT implementation.

Internship Qualifications:

• Currently enrolled in a bachelor’s degree in Pharmaceutical Sciences, Analytical Chemistry, Chemical/Biomedical Engineering, or a related field
• Experience working in a laboratory setting, operating laboratory equipment, recording data
• Interested in learning Lyophilization techniques, PAT, spectroscopy (NIR/IR), and/or analytical methods
• Comfortable working with data (e.g. Excel, JMP, or similar)
• Detail-oriented, structured, and able to document experimental work
• Effective communication skills

The following hourly pay rates reflect the anticipated base pay for this position:

If the selected candidate is a student pursuing an Associate-level degree: $16.00 per hour

If the selected candidate is a student pursuing an Undergraduate-level degree: $22.00 per hour

If the selected candidate is a student pursing a Graduate-level degree: $32.50 per hour

If the selected candidate is a student pursuing a Doctorate-level degree: $36.00 per hour

The following hourly pay rates reflect the anticipated base pay for this position if a selected candidate were to be located in California, Connecticut, District of Columbia, Illinois (Chicago area), Massachusetts, New Jersey, New York, Washington (Seattle area):

Student pursuing an Associate-level degree: $17.00 per hour

Student pursuing an Undergraduate-level degree: $24.20 per hour

Student pursing a Graduate-level degree: $36.40 per hour

Student pursuing a Doctorate-level degree: $40.30 per hour

Full timeIntern (Trainee)Colleague

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