Details:

  • Compensation: $75 - $100/hour
  • Benefits: Medical, Dental, Vision
  • Employment Classification: Contract
  • Status: On-Site
  • Job ID: 21581
Analytical Development and Biophysical Characterization Contractor

Job Title: Analytical Development and Biophysical Characterization Contractor

Work Location: Middlesex County, Massachusetts

Summary:

Seeking a senior-level contractor to lead analytical development and biophysical characterization for IND-enabling programs in the immuno-oncology space. This role involves technical leadership, cross-functional collaboration, and regulatory support for a portfolio of innovative therapeutic molecules.

Responsibilities:

  • Direct analytical strategy and serve as technical lead for multiple IND-enabling programs.
  • Oversee method development and qualification for physicochemical and biological assays at external partners.
  • Lead stability programs, including accelerated, plasma, and stress studies to inform candidate selection.
  • Utilize advanced biophysical tools such as DSC, SEC-MALS, MST, and CD for protein characterization.
  • Prepare and present data packages to project teams and senior leadership to support development decisions.
  • Drive regulatory contributions, including preparation of IND submissions and participation in agency interactions.
  • Manage external partnerships and lead method transfers with contract development and manufacturing organizations.
  • Support analytical platform development and contribute to the selection of therapeutic candidates.

Qualifications:

  • PhD in Biochemistry, Analytical Chemistry, Structural Biology, or a related discipline.
  • 8 to 12 years of industry experience in analytical development or biophysical characterization.
  • Hands-on expertise with SEC-MALS, DSC, DSF, MST, CD, and ELISA.
  • Experience managing external partnerships and leading method transfers.
  • Strong regulatory knowledge for biologics development, including IND submissions and agency interactions.
  • Excellent communication skills for both technical and non-technical audiences.
  • Experience with novel modalities such as bispecifics, trispecifics, or complex fusion proteins is a plus.
  • Background in stability and developability studies for therapeutic proteins preferred.
  • Track record in analytical platform development is advantageous.

Published Category: Analytical & Process Development

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