Process Development Associate
Core
Develop, qualify, and transfer analytical methods for therapeutic protein characterization to support regulatory filings and commercial process development.
Role type
Associate analytical chemist (process development)
Builds
Analytical methods and product characterization data for biologic medicines
Domain
Biotechnology / Therapeutic proteins
Required skills
HPLC, UPLC, Capillary Electrophoresis (CE), Mass Spectrometry (MS), chromatographic fractionation, peptide mapping, intact mass analysis, method qualification, GMP compliance, stability study design
Preferred skills
Method development for therapeutic proteins, Biochemistry, Analytical Chemistry, Protein Chemistry
Technologies
HPLC, UPLC, CE, LC-MS
Responsibilities
Perform method development and qualification studies using HPLC, UPLC, and CE platforms; Perform chromatographic fractionation, peptide mapping, intact mass, and other LC-MS studies; Author results in laboratory notebooks and method development reports; Participate in the maintenance of Attribute Sciences instruments; Coordinate and perform attribute identification and characterization studies; Conduct and coordinate accelerated stability studies; Perform evaluation of novel platform analytical technologies; Perform experiments to answer questions from health authorities; Collaborate with partner organizations during commercial process development and validation studies
Seniority
Associate, hands-on IC
