Head of Analytical Characterization & Method Development

Head (SM/AD/D) of Analytical Characterization and Method Development

Fully remote role | MA-based company

 

Our client is a Series B biotech startup developing best-in-class antibodies that can broadly neutralize SARS-CoV-2, SARS-CoV-1 and additional potentially emergent coronaviruses. We are hiring a Head of Analytical Characterization and Method Development with extensive hands-on analytical development as well as proficiency in the ability to manage activities at third party pharmaceutical manufacturers.

 

What You'll Do:

  • Support the external development of analytical methods.
  • Manage and oversee review of raw data packages associated with method qualifications/validations, release testing, stability testing, and other characterization testing of drug substances and drug products.
  • Support process characterization and process validation activities.
  • Support relevant vendors (CMOs/CTLs) during the development and characterization of the drug substance and drug product.
  • Travel to CMOs and CTLs as needed (when safe and appropriate).
  • Develop and ensure the delivery of high-quality documentation to meet global regulatory expectations for analytical methods and controls.
  • Address technical inquiries from regulatory agencies to support clinical trial and commercial marketing applications.
  • Provide regulatory strategy input regarding characterization and analytical comparability programs.

Who You Are:

  • Expertise in analytical sciences and regulatory/GMP requirements.
  • Track record in analytical development for different clinical-stage programs.
  • Proven ability to achieve results with external laboratories and manufacturing facilities.
  • Demonstrated and significant experience with analytical development and support of clinical and commercial protein-based biologics, preferably monoclonal antibodies.
  • Advanced degree in Biochemistry or related field, PhD preferred but not required.
  • Must be typically available during normal Eastern US time zone working hours.
  • Some conference calls outside of work hours are expected.