Senior Scientist, Analytical Development (Large Molecule)

Role

Lead analytical development for peptides, bioconjugates, and biologics from preclinical to commercialization, focusing on characterization, method validation, and transfer.

Responsibilities

develop and optimize analytical techniques (e.g., LC, mass spectrometry, capillary electrophoresis), support formulation and process development, contribute to CMC and regulatory activities, and ensure compliance with cGMP. Serve as an analytical lead on cross-functional teams, manage external testing and collaborations, and address complex characterization challenges through innovative approaches.

Requirements

BS/BA with 12+ years, MS with 10+ years, or PhD with 4+ years in Analytical Chemistry or related field; extensive hands-on experience in analytical method development, validation, and transfer; proficiency with LC, iCIEF, CE, MS, and additional characterization techniques; experience supporting drug substance and drug product development; strong communication and problem-solving skills; knowledge of cGMP, regulatory guidelines (FDA, EMA, ICH).

High-Value

biologics, peptides, bioconjugates, complex modalities, drug substance and drug product phases, CMC, regulatory compliance.

Collaboration

cross-functional teams, external labs, and partners.

WorkSetup

not specified.