Lead the global chemistry, manufacturing, and controls (CMC) strategy, process optimization, and contract manufacturing network for therapeutic oligonucleotides to ensure the seamless, compliant supply of drug substance and drug product across clinical pipeline phases.
Accountabilities:- Design and execute phase-appropriate global CMC development strategies for therapeutic oligonucleotides from late-stage discovery through advanced clinical testing to achieve corporate pipeline milestones.
- Direct external Contract Development and Manufacturing Organizations (CDMOs) and analytical testing laboratories, overseeing technology transfers, process scale-ups, and cGMP campaigns.
- Optimize solid-phase oligonucleotide synthesis, cleavage, deprotection, purification, and lyophilization processes to maximize production yields and ensure operational efficiency.
- Oversee the development, qualification, and validation of analytical methods for release testing, stability monitoring, and impurity characterization to maintain high product quality.
- Partner with the Quality Assurance team to review and approve master batch records, executed runs, and stability protocols to ensure unconditional compliance with cGMP and phase-appropriate regulatory guidelines.
- Author, review, and finalize CMC technical sections (Module 3) for global regulatory filings (including INDs, IMPDs, and NDAs) to facilitate rapid health authority approvals.
- Formulate technical data packages and precise written responses to CMC-related inquiries from global regulatory agencies (including the US FDA and EMA).
- Serve as the primary CMC representative on cross-functional program teams, collaborating closely with Discovery Biology, Translational Research, Regulatory Affairs, and Clinical Operations to ensure clinical trial material readiness.
- Forecast long-term chemical material needs and manage chemical raw inventory pools (including amidites and solid supports) to de-risk global clinical supply chains.
RequirementsRequired Knowledge and Experience- Demonstrated technical depth leading outsourced cGMP manufacturing operations and managing technology transfers with international CDMOs.
- Proven competence in therapeutic oligonucleotide chemistry (including ASOs, siRNA, and sgRNA), phosphoramidite workflows, conjugation strategies, and advanced purification techniques.
- Advanced working knowledge of analytical chemistry specific to oligonucleotides, with deep expertise in sequence confirmation, impurity profiling, and stability control strategies.
- Thorough understanding of global regulatory guidelines (ICH, FDA, and EMA) regarding the development, characterization, and manufacturing specifications of synthetic oligonucleotides.
- Exposure to or direct experience tracking targeted delivery systems for oligonucleotides, such as GalNAc conjugates or lipid nanoparticles (LNPs).
- Advanced educational background (PhD level preferred) in Organic Chemistry, Biochemistry, Chemical Engineering, or a highly related life sciences discipline.
