About the Role:We are seeking a versatile Director / Senior Director to lead early-stage CMC Drug Substance development in a virtual environment. The ideal candidate will have extensive experience in route scouting, process development, polymorphism, salt selection, crystallization, and production and solid-state development to improve solubility, stability, and PK. Experience managing toxic and mutagenic impurities and preparing regulatory documentation is highly preferred.
Key ResponsibilitiesRoute Scouting
- Propose alternative synthetic routes that optimize yield, purity, and scalability.
- Manage CDMOs to execute route scouting and scale-up to small demonstration batches.
Process Development
- Develop scalable, robust processes and purification strategies, including purging critical reagents and byproducts.
- Design processes capable of delivering large initial toxicology batches, especially when high NOAEL demands atypically large quantities.
- Support aggressive timelines where 13-week toxicology studies may run in parallel with Phase 1, requiring early establishment of a solid, scalable process.
Solid-State Development
- Lead solid-state development to enhance solubility, stability, and PK through salt or co-crystal formation.
- Hands-on experience in salt/co-crystal and polymorph screening, stability and solubility evaluation, and PK comparison.
- Develop crystallization processes, determine metastable zones, and establish control strategies for the desired form.
Production & Scale-Up
- Ensure timely delivery of materials with required quantity and purity under aggressive timelines.
- Lead development and execution of impurity-enriched 28-day toxicology batches, including scale-up and spiking of impurities.
- Support subsequent campaigns at increasing scale to meet Phase 1, Phase 2, and extended toxicology requirements.
Toxic Reagents & Mutagenic Impurities
- Develop and implement phase-appropriate strategies to identify, control, and purge toxic reagents, byproducts, and mutagenic impurities.
CMC Quality & Compliance
- Ensure adherence to cGMP standards and internal quality expectations.
- Review and approve manufacturing documentation, including batch records and deviation reports.
- Support audits, investigations, and continuous improvement initiatives.
Regulatory & Documentation Support
- Author and review CMC sections of regulatory filings (INDs, IMPDs, briefing packages, annual reports, amendments).
- Contribute to regulatory strategy and responses to health authority inquiries.
- Maintain comprehensive documentation to support product lifecycle management.
Cross-Functional & Strategic Contributions
- Collaborate with Drug Product, Analytical, Quality, Regulatory, Toxicology, and Clinical Supply teams.
- Provide scientific and operational input to project teams.
- Contribute to intellectual property strategy and cross-functional CMC initiatives.
Timeline & CDMO Leadership
- Develop and manage realistic timelines for R&D, manufacturing campaigns, and IND preparation aligned with clinical and toxicology milestones.
- Lead CDMOs proactively, providing clear guidance, actionable solutions, and rapid problem-solving.
Business Awareness & Late-Stage Development
- Understand the business value of CMC development and its impact on program strategy.
- Apply DoE and QbD principles for late-stage development (post-2029).
Qualifications- M.S. (15+ years) or Ph.D. (10+ years) in Organic Chemistry or related field.
- Expertise in small molecule synthesis, process development, and analytical method development for intermediates, drug substances, and structural alert impurities.
- Proven experience in impurity management, solid-state development/characterization, and GMP manufacturing.
- Demonstrated success in technology transfer and CDMO management.
- Experience authoring regulatory documents (INDs, IMPDs, amendments, annual reports).
- Experience managing GMP clinical supply, labeling, storage, and shipment.
- Strong leadership, collaboration, and communication skills; ability to influence across disciplines.
- Excellent interpersonal, technical writing, presentation and oral communication skills.
- Strong business awareness and ability to prioritize in a fast-moving, lean organization.
- Willingness to travel domestically and internationally as needed.
Ideal Candidate- Expected to operate with high ownership, accountability for delivery, timelines, and decision-making in a lean, fast-paced organization.
Benefits:Superluminal offers a comprehensive benefits package that fully covers employees' annual deductibles and monthly premiums for medical, dental, and vision insurance. The package also includes a 401(k) match program, a Massachusetts transportation subsidy, equity, unlimited paid time off, and both disability and life insurance.
