Director/Sr Director CMC & Regulatory Operations

Director/Senior Director, CMC & Regulatory Operations Reports to: Chief Operating Officer Location: U.S.-based, preferably the Boston area; flexible/hybrid Employment Type: Full-Time Position Summary OrthoBio Therapeutics is seeking an experienced CMC & Regulatory Operations leader to provide internal leadership and accountability for Chemistry, Manufacturing and Controls (CMC), manufacturing, clinical supply, and Regulatory Operations as the company advances its lead program through IND submission and into first-in-human clinical development. This individual will serve as the company's internal CMC and Regulatory Operations owner, integrating activities across internal scientific and clinical leadership, external consultants, CDMOs, testing laboratories, raw material suppliers, quality partners, regulatory resources, clinical sites, and other development partners. The role is designed for a lean biotechnology operating model in which significant technical and manufacturing capabilities remain outsourced. Success requires the ability to lead through external partners while maintaining strong internal sponsor ownership to establish clear requirements, plans, accountabilities, timelines, budgets, risk controls, and escalation pathways. The Senior Director will work closely with the CSO on scientific and technical strategy, the COO on operational execution and external partner performance, and Clinical Operations on clinical supply and technical requirements necessary to successfully initiate and conduct the company's first-in-human clinical trial. Key Responsibilities Own and maintain the integrated CMC development plan supporting IND submission and progression into Phase II clinical development. Translate regulatory strategy and FDA feedback into executable CMC workplans, milestones, deliverables, and decision points. Ensure required CMC documentation, data, specifications, analytical methods, stability information, manufacturing records, and supporting reports are complete and available according to IND timelines. Lead CMC readiness assessments and identify gaps, dependencies, risks, and mitigation plans. Coordinate preparation and review of CMC sections of regulatory submissions in partnership with Regulatory Affairs and external subject-matter experts. Maintain clear visibility to critical-path CMC deliverables and proactively elevate risks that could affect IND submission, trial initiation, or clinical supply. Manufacturing & Regulatory Operations Provide sponsor-side leadership and oversight of drug substance, drug product, formulation, fill/finish, testing, release, and stability activities performed by external partners. Oversee engineering, demonstration, and GMP manufacturing campaigns and ensure appropriate readiness reviews are completed before execution. Coordinate technology transfer activities across development and manufacturing partners. Ensure manufacturing plans, specifications, analytical requirements, batch documentation, deviations, investigations, and change controls are appropriately reviewed and resolved. Establish manufacturing readiness criteria and track execution against schedule, quality, cost, and technical expectations. Ensure sufficient institutional knowledge of the manufacturing process and control strategy resides within OrthoBio. Clinical Supply & Human Clinical Trial Support Own the integrated clinical supply strategy and ensure GMP drug product is available to support trial initiation, enrollment, dosing, and completion. Develop and maintain supply forecasts, inventory controls, shelf-life plans, and contingency strategies aligned with the clinical protocol and enrollment plan. Oversee clinical packaging, labeling, storage, distribution, accountability, reconciliation, and final disposition of investigational product. Ensure site and pharmacy readiness, including clear requirements for product handling, preparation, storage, administration, and technical support. Partner with Clinical Operations, Quality, Medical, and Regulatory to assess and resolve manufacturing, stability, shipment, complaint, or supply risks that could affect study conduct. Develop and maintain an integrated CMC and clinical supply project plan connecting activities, dependencies, resources, costs, and critical milestones. Establish monthly resource and spend forecasts across CMC consultants, CDMOs, laboratories, suppliers, and clinical supply activities. Track actual performance and spend against plan and proactively identify potential variances. Ensure external resources are deployed against clearly defined deliverables and at the appropriate level of expertise. Recommend when capabilities should remain outsourced versus when internal ownership would provide greater efficiency, continuity, or strategic value. Quality & Sponsor Oversight Partner with Quality to ensure appropriate sponsor oversight of GMP activities and external manufacturing organizations. Support Quality Technical Agreements, vendor qualification, audits, deviation and investigation oversight, change control, product release, and inspection readiness. Ensure CMC and clinical supply activities and documentation are conducted in accordance with applicable regulatory requirements and phase-appropriate quality standards. Support development of scalable CMC governance and documentation practices appropriate for a clinical-stage biotechnology company. Ensure appropriate documentation and traceability for clinical supply activities throughout the clinical trial. Qualifications Bachelor's degree in pharmaceutical sciences, chemistry, chemical engineering, biotechnology, bioengineering, or related discipline; advanced degree preferred. 10+ years of biotechnology/pharmaceutical industry experience, with significant experience in CMC, Regulatory Operations, manufacturing, or pharmaceutical development. Demonstrated experience supporting products through IND/CTA submission and first-in-human or early-stage clinical development. Direct experience supporting clinical supply planning and execution for Phase I/II clinical trials strongly preferred. Strong working knowledge of GMP manufacturing, analytical development/testing, specifications, stability, product release, clinical packaging/distribution, and clinical supply management. Experience with biologics, nucleic-acid therapeutics, lipid nanoparticles, gene editing, or other complex modalities strongly preferred. Working knowledge of FDA CMC expectations and preparation/review of regulatory submission content. Demonstrated ability to manage complex cross-functional programs involving multiple external organizations. #J-18808-Ljbffr OrthoBio Therapeutics Inc.