Senior Consultant

Responsibilities

• Oversee the design, validation, and execution of analytical methods for oligonucleotides and peptides


• Perform characterization, stability testing, and process control strategies


• Manage the transfer of phase appropriate analytical methods to CDMO partners


• Ensure compliance with FDA, EMA, and ICH regulatory guidelines


• Prepare and review regulatory submissions including INDs and CTAs


• Collaborate with CMC teams, formulation scientists, and quality assurance


• Mentor junior staff and provide guidance on analytical techniques

Requirements

• Minimum of 10 years of experience in analytical chemistry


• Specialized expertise in oligonucleotide and peptide analysis


• Strong understanding of regulatory guidance and submission preparation


• Proven ability to work cross-functio...