Associate Director / Director, Analytical Development (CMC)

Company Overview

SanegeneBio is a clinical-stage biotechnology company developing innovative genetic medicines based on RNAi (RNA interference) technology. Powered by the proprietary LEAD™ (Ligand and Enhancer Assisted Delivery) platform, the company is advancing a growing pipeline across cardiometabolic and complement-mediated diseases. With R&D operations in Boston, Suzhou, and Shanghai, SanegeneBio is committed to scientific rigor, operational excellence, and delivering transformative therapies.

Summary

SanegeneBio is seeking an experienced Analytical Development leader to drive analytical strategy across non-clinical and clinical-stage RNAi programs. This role will be responsible for analytical support of drug substance and drug product development, with primary emphasis on external GMP manufacturing, analytical control strategy, and phase-appropriate methods and specifications to support clinical and regulatory milestones.

The individual will serve as a key technical leader across internal teams and external CDMOs, providing independent scientific judgment on analytical readiness, data quality, and development risk. This role will work closely with the Head of Process Development / Manufacturing and internal analytical resources to ensure strong alignment across development, manufacturing, release, stability, and regulatory activities.

Key Responsibilities

• Lead analytical development strategy for drug substance, drug product, intermediates, and key raw materials across multiple RNAi programs

• Define phase-appropriate analytical control strategies, including specifications, method lifecycle plans, and support for retest and shelf-life assignment

• Lead analytical oversight of external CDMOs and contract laboratories supporting GMP manufacturing, release, stability, investigations, and method transfer activities

• Ensure analytical readiness for GMP manufacturing campaigns, including support for release testing, stability programs, comparability assessments, and change implementation

• Critically evaluate analytical data, identify risks and gaps, and provide clear recommendations to support development, manufacturing, and regulatory decisions

• Partner closely with the process and manufacturing team to provide integrated CMC support across process, analytical, and manufacturing activities

• Drive investigations, troubleshooting, and resolution of analytical and quality issues, including support for deviations, OOS/OOT as applicable

• Contribute to and review CMC sections of regulatory submissions, including IND/CTA and, as applicable, later-stage filings

• Represent Analytical Development in cross-functional discussions and influence development strategy, manufacturing readiness, and key CMC decisions

• Mentor junior team members and help build internal analytical capabilities, processes, and best practices

Qualifications

• Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, or related field with 8 years (Associate Director) or 10 years (Director) of relevant industry experience (MS/BS with significant experience may be considered)
• Strong experience in analytical development for oligonucleotides or related modalities
• Hands-on and technical expertise in HPLC (e.g., AEX, RP, SEC) and LC-MS
• Experience with method development, qualification/validation, and transfer
• Prior experience working with external CDMOs and contract laboratories is strongly preferred
• Familiarity with CMC regulatory expectations for early- to late-stage development
• Solid understanding of cGMP requirements and data integrity
• Ability to critically evaluate data and identify risks and gaps
• Strong communication skills and ability to work effectively in cross-functional teams
• Comfortable operating in a fast-paced environment with shifting priorities

Benefits

• Medical, dental, and vision insurance
• 401(k) with company match
• Annual bonus and equity compensation
• HSA/FSA programs