Analytical Development & Biophysical Characterization Principal Scientist / Associate Director

CONTRACTOR OPPORTUNITY | Analytical Development & Biophysical Characterization Principal Scientist / Associate Director Level Clinical-Stage Biotech | Cambridge, MA | Contract

ClinLab Solutions Group has been engaged by a clinical-stage immuno-oncology biotech to identify a senior Analytical Development contractor supporting their IND-enabling pipeline. This company is advancing a portfolio of novel, tumor-activated I-O molecules designed to optimize the therapeutic index by localizing anti-tumor activity within the tumor microenvironment.

This is a high-visibility engagement with direct exposure to project teams and senior leadership across multiple programs.

What You'll Be Doing

You will own the analytical strategy across multiple programs at the IND-enabling stage, serving as the technical lead for both external CDMO partnerships and internal biophysical characterization efforts. Day to day, this includes:

• Overseeing method development and qualification at CDMOs for physicochemical and biological assays
• Leading stability programs including accelerated, plasma, and stress studies to support candidate selection
• Applying advanced biophysical tools (DSC, SEC-MALS, MST, CD) to characterize protein behavior and inform molecule design decisions
• Supporting development candidate selection through data packages and direct presentations to project teams and senior leadership
• Driving regulatory contributions including IND submissions and agency interactions

What You Bring

• PhD in Biochemistry, Analytical Chemistry, Structural Biology, or a related field
• 8 to 12 years of industry experience in analytical development or biophysical characterization
• Hands-on proficiency with SEC-MALS, DSC, DSF, MST, CD, and ELISA
• Demonstrated experience managing CDMO partnerships and leading method transfers
• Strong regulatory fluency for biologics development
• Excellent communication skills across technical and non-technical audiences

Preferred

• Experience with novel modalities: bispecifics, trispecifics, or complex fusion proteins
• Track record in stability and developability studies for therapeutic proteins
• Prior IND submissions and direct regulatory agency interaction
• Background in analytical platform development