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-functionally within CMC teams
• Ability to work independently with minimal supervision
• Willingness to travel occasionally to client sites

Preferred Qualifications

• PhD in Chemistry, Analytical Chemistry, Biochemistry, or a related field

About the Company

Syner-G is a strategic biopharma product development and delivery partner that accelerates breakthrough science and the delivery of life-enhancing therapies to patients.