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Superluminal Medicines is a generative biology and chemistry company using deep biology, computational chemistry, machine learning, and proprietary data infrastructure to accelerate small molecule drug discovery. The company seeks a Director of CMC Drug Substance to lead early-stage chemistry, manufacturing, and controls development in a virtual environment.
The role encompasses comprehensive CMC leadership across route scouting, process development, solid-state development, production scale-up, and regulatory compliance. Key responsibilities include proposing and executing alternative synthetic routes optimized for yield, purity, and scalability; managing contract development and manufacturing organizations (CDMOs) through route scouting and scale-up campaigns; developing robust, scalable processes and purification strategies capable of delivering large toxicology batches under aggressive timelines where 13-week studies may run parallel to Phase 1 clinical work.
Solid-state development work involves leading salt, co-crystal, and polymorph screening to enhance solubility, stability, and pharmacokinetics; developing crystallization processes and control strategies. The director will manage toxic reagents and mutagenic impurities, implementing phase-appropriate identification, control, and purging strategies. Production and scale-up responsibilities include ensuring timely delivery of materials meeting quantity and purity requirements, leading impurity-enriched toxicology batch campaigns, and supporting subsequent manufacturing campaigns at increasing scale.
CMC quality and compliance duties include ensuring cGMP adherence, reviewing manufacturing documentation and batch records, and supporting audits and investigations. Regulatory work involves authoring and reviewing CMC sections of regulatory filings (INDs, IMPDs, briefing packages, annual reports, amendments) and contributing to regulatory strategy and health authority responses.
Cross-functional collaboration with Drug Product, Analytical, Quality, Regulatory, Toxicology, and Clinical Supply teams is essential. The director will develop realistic timelines aligned with clinical and toxicology milestones, lead CDMOs proactively with clear guidance and rapid problem-solving, understand business value and program strategy implications, and apply Design of Experiments (DoE) and Quality by Design (QbD) principles for late-stage development.
Required qualifications include M.S. with 15+ years or Ph.D. with 10+ years in Organic Chemistry or related field; expertise in small molecule synthesis, process development, and analytical method development; proven experience in impurity management, solid-state development and characterization, and GMP manufacturing; demonstrated success in technology transfer and CDMO management; experience authoring regulatory documents; and experience managing GMP clinical supply, labeling, storage, and shipment.
