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.