Manage and lead Analytical Development activities to support early to late phase programs, including monoclonal antibodies and other biologics modalities
Job Summary
Manage and lead Analytical Development activities to support early to late phase programs, including monoclonal antibodies and other biologics modalities.
Design, develop, and implement analytical methods for the testing and characterization of biologics programs including monoclonal antibodies and other biologics modalities.
Collaborate with cross-functional teams, including process development and R&D, to support project goals and timelines.
Matching Summary
Manage and lead Analytical Development activities to support early to late phase programs, including monoclonal antibodies and other biologics modalities.
Salary
$175,000 – $195,000 /year
Skills & Requirements
Must-have
Develop analytical methods for biologics
Method development and validation
Product characterization and comparability
Experience with mass spectrometry and chromatography
Collaborate with cross-functional teams
Nice-to-have
Experience with ELISA and bioassays
Work with external contract organizations
Exhibit C.O.R.E. values
Key Requirements
PhD in Analytical Chemistry, Biochemistry, or related field
Minimum of 7 years of relevant industry experience
Familiarity with regulatory requirements (FDA, ICH)