Director, Solid Oral Formulations

Director, Solid Oral Formulation

The Director, Solid Oral Formulation serves as the technical lead and subject matter expert (SME) for oral solid dosage form development, scale-up, validation (PPQ), commercial manufacturing, and lifecycle management. This role is responsible for providing strategic and technical oversight of external CDMO partners supporting Phase 3, registration, commercial launch, and post-approval operations.

The Director will lead formulation and process optimization initiatives to ensure robust, scalable, and commercially viable tablet manufacturing processes while maintaining regulatory compliance and inspection readiness. Working cross-functionally with CMC, MSAT, Quality, Regulatory Affairs, Supply Chain, Technical Operations, and external manufacturing partners, this individual will drive successful commercialization, process validation, Pre-Approval Inspection (PAI) readiness, and ongoing process performance verification throughout the product lifecycle.

The main responsibilities of this role include:

• Serve as the company's technical SME for solid oral dosage forms, including immediate-release, modified-release, and specialty tablet technologies.
• Provide strategic leadership for formulation optimization, process characterization, scale-up, technology transfer, validation, and commercial manufacturing.
• Lead development and implementation of control strategies aligned with Quality by Design (QbD) principles and commercial product requirements.
• Drive scientific evaluations and risk assessments supporting formulation improvements, process robustness, and manufacturing efficiency.

• Provide technical oversight and governance of CDMO partners responsible for Phase 3, registration, exhibit, and commercial tablet manufacturing activities.
• Establish performance expectations and ensure execution of manufacturing, validation, stability, and regulatory commitments.
• Review and approve manufacturing strategies, process development plans, protocols, reports, investigations, and change controls.
• Lead regular technical and operational reviews with CDMO partners to monitor compliance, project execution, quality metrics, capacity planning, and continuous improvement initiatives.
• Assess CDMO readiness for commercial supply and regulatory inspections.

• Lead process optimization activities focused on blending, granulation, compression, coating, tablet finishing, packaging, and distribution readiness.
• Oversee process characterization studies and design-of-experiment (DoE) activities supporting process validation and regulatory filings.
• Provide technical leadership for technology transfer activities between development, pilot, and commercial manufacturing sites.
• Review and approve validation strategies, including process performance qualification (PPQ), cleaning validation, hold-time studies, and continued process verification programs.
• Ensure commercial processes are capable, reproducible, and aligned with established critical quality attributes (CQAs) and critical process parameters (CPPs).

• Lead technical preparation for FDA, EMA, MHRA, PMDA, and other regulatory agency inspections.
• Serve as the manufacturing and formulation SME during Pre-Approval Inspections (PAI), regulatory audits, and health authority interactions.
• Ensure manufacturing processes, development history, technical reports, validation packages, and control strategies support successful regulatory review.
• Author, review, and approve CMC regulatory documentation, including Module 3 submissions, amendments, responses to health authority questions, comparability assessments, and post-approval change submissions.
• Partner with Quality and Regulatory Affairs to identify and mitigate compliance and regulatory risks.

• Support commercial launch readiness activities, including inventory strategy, manufacturing capacity planning, process validation completion, and supply chain risk management.
• Lead technical assessments and implementation of process improvements, cost-of-goods reduction initiatives, yield optimization, and manufacturing efficiencies.
• Evaluate and approve commercial manufacturing changes through formal change control processes.
• Support annual product reviews, continued process verification, deviation investigations, root-cause analyses, and CAPA implementation.
• Develop long-term product lifecycle strategies to ensure sustainable commercial supply and regulatory compliance.

• Collaborate across Technical Operations, CMC, Quality Assurance, Regulatory Affairs, Clinical Supply, Supply Chain, and Program Management functions.
• Communicate technical strategies, risks, mitigation plans, and recommendations to senior leadership and executive management.
• Mentor junior scientists and manufacturing professionals while fostering a culture of…