Responsibilities:
- Optimize discovery-stage conjugation protocols for antibody-siRNA conjugates, improving yield, reproducibility, and product quality to enable scale-up.
- Develop GMP-ready, kilogram-scale conjugation processes, including site-specific and stochastic conjugation strategies, linker chemistry, and payload attachment.
- Hands-on in the laboratory to design, execute, and optimize conjugation reactions, purification (chromatography, TFF/UF-DF), and analytical control strategies.
- Oversee and direct CROs/CDMOs for process development and manufacturing, including setting technical direction, reviewing data, and ensuring timelines and quality standards.
- Characterize conjugates for DAR/siRNA-to-antibody ratio, aggregation, charge heterogeneity, and stability using methods such as HIC, SEC, IEX, LC-MS, and AEX.
- Lead technology transfer, authoring process descriptions, batch records, and development reports.
- Troubleshoot process and analytical challenges; design experiments to define parameters/ranges and robustness for kilogram-scale operation.
- Collaborate cross-functionally with discovery chemistry, linker/conjugation chemistry, analytical development, and CMC teams.
Requirements:
- PhD in Organic Chemistry, Bioconjugate Chemistry, Chemical Engineering, or related field; or Bachelorβs/Masterβs with commensurate hands-on industry experience.
- Demonstrated hands-on experience in siRNA conjugation development.
- Working knowledge of oligonucleotide and/or antibody chemistry, linker design, and bioconjugation methods.
- Familiarity with purification and analytical characterization of conjugates.
- Strong problem-solving, documentation, and communication skills.
Preferred:
- Experience with AOCs or ADCs.
- Experience developing/scaling to GMP/kilogram scale and managing CRO/CDMO relationships.
- Knowledge of site-specific conjugation technologies (e.g., engineered cysteines, enzymatic/click chemistry).
- Experience with tech transfer and CMC/GMP environments.