Acting as both architect and chief problem-solver, the Head of Chemistry, Manufacturing & Controls (CMC) shapes the technical dimensions of our oncology pipeline of AAV-packaged DNA computing payloads. From the time of conception of a therapeutic program, you will develop a phase-appropriate, risk-based CMC roadmap that converts scientific promise into GMP-ready product. You will build our manufacturing platform including the selection of cell lines, securing plasmid supply, configuring upstream and downstream processes and fill-finish. You will also oversee analytical development and quality control from early-stage research through clinical development and commercialization. Day-to-day, you will manage a lean internal team and a range of CDMOs, raw-material vendors and QC labs. You will author and defend CMC sections of INDs, and serve as the company’s face in FDA and other global agency interactions. As programs mature, you will drive tech transfers, process-performance qualification and cost-of-goods optimization, while instilling a culture of data integrity, electronic batch records and phase-appropriate GMP. Beyond the bench, you will translate complex technical risk into clear board-level decisions, ensuring manufacturing, supply-chain and quality strategies keep pace with aggressive growth plans. The ideal candidate will possess deep expertise in AAV manufacturing, a strong understanding of regulatory requirements for gene therapies, and a proven track record of successful CMC leadership in the biotech or pharmaceutical industry.