Senior Director, Manufacturing Science and Technology

Overview

Our client is an ambitious and globally successful biopharmaceutical company with a robust commercial portfolio and a promising drug pipeline. This well-managed and high-performing organization values best practices in all aspects of its operations and boasts a motivated workforce ready for rapid expansion.

Role Summary

The Senior Director of Manufacturing Science and Technology (MSAT) will serve as a strategic leader within the Technical Operations team. Reporting directly to the VP of Technical Operations, this role is accountable for ensuring the technical oversight and lifecycle management of commercial manufacturing processes throughout a global network. The position demands driving excellence and capability development across an evolving and complex product portfolio, acting as the scientific and industrialization cornerstone in partnership with Pharmaceutical Development from late-stage development through commercialization.

Key Responsibilities

• Own technical stewardship by maintaining product and process knowledge, managing technical risks, and defining lifecycle strategies to ensure process integrity.
• Establish and implement standardized methodologies for technical investigations, statistical trending, process control, and monitoring product performance to assure robust and reliable manufacturing of APIs and drug products.
• Develop and sustain systems for tracking Critical Process Parameters (CPPs) and conducting Continuous Process Verification (CPV) to maintain compliance and high performance.
• Guide design and optimization of commercial processes to improve process robustness, increase yields, and support scale-up activities. Contribute technical leadership to Operations Lifecycle Management (OLM) projects and continuous improvement.
• Lead enhancements of technical transfer systems and cross-functional workflows to enable efficient product scale-up, validation, and launch in manufacturing facilities and Contract Manufacturing Organizations (CMOs).
• Build strong collaborative relationships with departments including Quality, Manufacturing Operations, Regulatory CMC, Supply Chain, Finance, and Pharmaceutical Development to achieve portfolio goals and communicate effectively with senior leadership on risks and opportunities.
• Promote the adoption of digital tools, automation, and advanced analytics to boost process visibility, enable predictive insights, and speed up decision-making within Technical Operations.
• Evaluate and deploy innovative manufacturing technologies and equipment to improve performance, dependability, and scalability.
• Lead, mentor, and develop a high-performing MSAT team fostering accountability, innovation, and continuous improvement.

Qualifications and Experience

• Advanced degree (Master's or PhD) in Chemical Engineering, Pharmaceutical Sciences, or related technical fields is preferred.
• At least 15 years of relevant experience demonstrating leadership in pharmaceutical manufacturing, technical operations, or process development, including managing internal and external CMO networks.
• Expertise in MSAT with a strong foundation in controlling product quality attributes and pharmaceutical process fundamentals, particularly in oral solid dosage (OSD) manufacturing.
• Proven success in CMC activities, technology transfer, scale-up, validation, and commercialization of pharmaceutical products.
• Experience managing relationships and technical operations across external partner networks and CMOs.
• Strong financial and business acumen including cost analysis, budgeting, forecasting, and building business cases for strategic decisions.
• Background in operational excellence methodologies such as Lean or Six Sigma, with demonstrated continuous improvement results.
• In-depth understanding of global regulatory standards including cGMP, ICH guidelines, and audit readiness, with experience managing inspections and regulatory responses.
• Outstanding leadership capability leading high-performing technical teams in complex, global, or matrix environments.

Additional Knowledge Areas

• Pharmaceutical Manufacturing and CMC regulatory frameworks and GMP operations.
• Emerging trends in digital transformation including automation and data analytics for operations enhancement.
• Experience with governance, risk management, KPIs, performance dashboards, and organizational development including capability and leadership growth.

Contact Information

Interested candidates should send their CV to the provided contact email or phone number for consideration.