Senior Director – Commercial Manufacturing Readiness (MS&T)

Job Title

Senior Director – Commercial Manufacturing Readiness (MS&T)

Company Name

Solid Biosciences

Solid Summary

Solid Biosciences is a life science company focused on advancing a portfolio of neuromuscular and cardiac programs, including SGT-003, a differentiated gene therapy candidate for the treatment of Duchenne, AVB-401, a gene therapy program for the treatment of BAG3 mediated dilated cardiomyopathy, SGT-212, a gene therapy program for the treatment of Friedreich’s Ataxia, and additional assets for the treatment of fatal cardiac diseases. Solid aims to be the center of excellence across a given disease spectrum bringing together those with expertise in science, technology, disease management, and care. Patient-focused and founded by those directly impacted, Solid’s mandate is to improve the daily lives of patients living with these devastating diseases.

Position Summary

SolidBio is seeking an experienced and highly motivated Senior Director of Commercial Manufacturing Readiness. This position will lead the technical and operational transition from clinical-stage to commercial-stage manufacturing, ensuring that our processes, systems, and infrastructure are built for compliant, efficient, and scalable manufacturing operations. This is a critical role in shaping our external manufacturing strategy and enabling long-term global supply for patients.

The ideal candidate will bring deep experience in Manufacturing Sciences and Technology, validation, technology transfer, and the establishment of manufacturing policies, systems, and procedures that meet global regulatory requirements. This will lead in a matrix environment to bridge process science and operations with a future-ready mindset and will ensure our manufacturing organization is fully prepared for commercial supply and regulatory inspections.

Key Duties & Accountabilities

• Lead the commercial manufacturing readiness strategy from late clinical through commercial launch, including systems, compliance frameworks, and cross-functional processes required for commercialization.
• Develop and implement GMP-compliant policies, SOPs, and documentation frameworks suitable for a manufacturing organization supporting commercial supply at contract manufacturing organizations that align with commercial regulations and industry best practices.
• Ensure all manufacturing systems, documentation, and operations are inspection-ready and compliant with global regulatory agency expectations for commercial-stage biologics (FDA, EMA, etc.).
• Build readiness plans for external manufacturing including gap assessments, remediation planning, facility readiness, and process validation oversight.
• Provide strategic direction for tech transfer, scale-up, and commercial process validation activities in collaboration with Process Sciences, MSAT, and Quality.
• Ensure tech transfers are executed with thorough documentation, risk mitigation strategies, and alignment across Manufacturing, Quality, and Regulatory.
• Build and maintain strong CDMO governance structures, including technical business reviews, KPIs, and escalation pathways to ensure operational excellence and compliance.
• Provide technical expertise in the evaluation and resolution of deviations, CAPAs, and change controls, ensuring alignment with quality expectations and internal risk management strategies.
• Lead the integration of data science tools, statistical modeling, and digital solutions (e.g., dashboards, predictive analytics) in conjunction with Process Development, Process Sciences, and MSAT to support proactive decision-making and process optimization.
• Support the design and execution of a comprehensive process monitoring program to provide ongoing process performance monitoring, data analytics, and data science integration.
• Collaborate with CDMOs to ensure real-time data capture, visualization, and review mechanisms are in place for process health monitoring and early identification of deviations or drift.
• Develop training programs, operational playbooks, and knowledge management systems to enable sustainable, compliant manufacturing operations.

Core Competencies Required

• Deep understanding of biologics manufacturing processes (e.g., upstream/downstream, DS/DP, fill-finish).
• Expertise in process validation, control strategies, and lifecycle management (CPV).
• Strong working knowledge of GMP regulations and global regulatory expectations (FDA, EMA, ICH).
• Knowledge of GMP documentation systems, SOP governance, and regulatory inspection preparation.
• Proven ability to manage and influence external CDMO partners in a fully outsourced model.
• In-depth knowledge of global regulatory requirements (FDA, EMA, ICH), with demonstrated experience supporting BLA/MAA submissions and pre-approval inspections.
• Ability to derive insights from manufacturing data to support risk-based decision-making and continuous improvement.
• Able to analyze complex datasets and apply data science principles to drive process improvement and operational decision-making.
• Build strong relationships across functions and CDMOs, effectively aligning stakeholders without direct authority.
• Align communication, accountabilities, resource capabilities, internal processes to ensure that strategic priorities yield measurable and sustainable results.
• Clearly conveys complex technical information to diverse audiences and develops high-performing, motivated teams.
• Able to multitask and handle multiple competing priorities and projects at once in a changing and fast-paced environment.

Knowledge: Education, Experience, & Skills

Degree in Chemical/Biomedical Engineering, Pharmaceutical Sciences, Biochemistry, or related discipline with 15+ years of progressing experience in biologics manufacturing and technical operations, with a focus on late-stage clinical and commercial readiness.

Preferred Skills

• Proven leadership in MS&T, process validation, and commercial readiness within outsourced manufacturing networks.
• Direct experience overseeing CDMO-based manufacturing models, including technology transfer, CDMO governance, and external quality/compliance collaboration.
• Demonstrated expertise in evaluating and resolving complex deviations (including OOS manufacturing investigations and/or SWAT style investigation teams), developing robust CAPAs, and implementation strategies for change controls. Ability to coach principles to develop depth of experience in matrixed team members.
• Strong expertise in process development, tech transfer, and lifecycle management of biologic products (e.g., Gene Therapy, monoclonal antibodies, fusion proteins, or other complex modalities).
• Experience in mentoring and coaching junior team members and conducts oneself in a way that encourages team members to ask for advice and help when needed.
• Demonstrated ability to facilitate project team meetings, enhance cross-functional communication, support decision making, influence outcomes, and ensure alignment among internal and external stakeholders.
• Self-directed individual who is able to work effectively with limited direction in a complex, fast-paced environment.

Travel Commitment

Up to 15% travel will be required at times.

Role Location

Remote