MS&T Senior Director

The RFT Group; Leinster; On-site; EUR 180,000 - 260,000; Full time

Job summary

The RFT Group is seeking a Senior Director MSAT for a leading global biopharmaceutical client. You will shape technical capability and lead lifecycle management across a complex commercial portfolio.

Reporting to the VP of Technical Operations, you will drive process robustness, CPV, and digital analytics while guiding a high-performing MSAT team in a matrix, global setting.

Qualifications

• Advanced degree preferred - master's or PhD in Chemical Engineering, Pharmaceutical Sciences, or related field.
• Minimum of 15 years’ relevant experience in pharmaceutical manufacturing, technical operations, or process development.
• MSAT expertise - deep understanding of product quality attributes control strategies for pharmaceutical processes.
• CMC and Tech Transfer expertise - proven success in tech transfer, scale-up, validation, and commercialization.
• External network management – experience managing technical operations across CMOs and external partners.
• Financial acumen - budgeting, forecasting, and business-case development.

Responsibilities

• Provide technical ownership and lifecycle strategy for commercial manufacturing processes.
• Define and implement standardized approaches for investigations, CPV, and process performance monitoring.
• Lead the design and optimization of manufacturing processes, including scale-up and transfer to CMOs.
• Mentor and grow a high-performing MSAT team and drive continuous improvement.
• Foster cross-functional partnerships with Quality, Regulatory, Supply Chain, and Development.

Skills

MSAT expertise

Lean Six Sigma

Regulatory knowledge

Leadership

Education

Master's degree or PhD in Chemical Engineering or Pharmaceutical Sciences

Job description

Our client is a highly successful, and ambitious global biopharmaceutical company with a strong commercial portfolio and drug pipeline. With a passion for best practice in every aspect of its business, this well-managed, high performing company has a motivated workforce an exciting pipeline and is poised for rapid growth.

Job Spec

The Senior Director MSAT will serve as a senior leader within the Technical Operations organisation, playing a central role in shaping future technical capability and driving sustained excellence across a complex and expanding portfolio.

Reporting to the VP, Technical Operations, the Snr. Director will be accountable for the technical oversight and lifecycle management of commercial manufacturing processes across a global network. The Snr. Director will play a key role in ensuring robust, compliant, and reliable manufacture of commercial products. This leader will also serve as the scientific and industrialization engine for Technical Operations partnering closely with Pharmaceutical Development during late-stage development through to commercialisation.

We are seeking a highly motivated individual with expertise in process science, development and commercial manufacturing, to provide strong organisational, strategic, and scientific leadership to a newly forming MSAT organisation.

Key areas of accountability:

Technical Ownership & Process Stewardship

Provide technical stewardship of manufacturing processes ensuring organizational ownership and retention of product knowledge, process knowledge, technical risk, and lifecycle strategy.

Process Robustness and Performance

Define and implement standardized approaches for technical investigations, statistical analysis/trending, process control and product performance monitoring. Ensure API and Drug Product processes are robust, reliable, and capable of consistently delivering high-quality products.

Process Monitoring

Establish and maintain systems and processes for identifying and controlling Critical Process Parameters (CPPs) and executing Continuous Process Verification (CPV) to ensure ongoing compliance and performance.

Lifecycle Support and Improvement

Provide guidance to the design and optimization of commercial manufacturing processes including process robustness, yield optimisation and process scale up. Support Operations Lifecycle Management (OLM) programs by contributing technical leadership to key projects and continuous improvement initiatives.

Technical Transfer

Develop/enhance systems, tools, and cross-functional processes that support the efficient transfer of new products into manufacturing facilities and CMOs. Provide technical leadership to proactively identify and resolve challenges during scale-up, validation, and launch phases.

Business Partnerships

Establish strong relationships with Quality, Manufacturing Operations, Regulatory CMC, Supply Chain, Finance and Pharmaceutical Development to ensure timely delivery of late stage and commercial portfolios goals. Influence stakeholders and communicate with senior leadership on issues, risks, and opportunities.

Digital and Data

Champion the integration of digital tools, automation, and advanced analytics to enhance process visibility, enable predictive insights, and accelerate decision-making across the technical operations landscape.

Innovative Technologies and Equipment

Assess and implement new technologies and equipment that enhance manufacturing performance, reliability, and scalability.

Develop and Empower the MSAT Team

Lead, mentor, and grow a high-performing team. Foster a culture of accountability, innovation, and continuous improvement through strong leadership and capability development.

Person Spec

Advanced Degree Preferred - master's or PhD in Chemical Engineering, Pharmaceutical Sciences, or a related technical field.

Minimum of 15 years’ relevant experience - Proven leadership in pharmaceutical manufacturing, technical operations, or process development, including oversight of internal and external (CMO) networks.

MSAT expertise - Deep understanding of product quality attributes control strategies as applied to pharmaceutical processes. Sound background in processing and engineering fundamentals, particularly in the OSD space.

CMC and Tech Transfer Expertise - Demonstrated success in technology transfer, scale-up, validation, and commercialisation of pharmaceutical products.

External Network Management - Experience managing technical operations across CMOs and external partners.

Financial and Business Acumen - Skilled in cost analysis, budgeting, forecasting, and preparing business cases to support strategic decision-making.

Operational Excellence Mindset - Solid background in Lean, Six Sigma, or similar methodologies with a track record of driving continuous improvement.

Regulatory and Audit Readiness - Deep understanding of cGMP, ICH, and global regulatory expectations; experience supporting inspections and managing responses.

People Leadership - Proven ability to lead, develop, and inspire high-performing technical teams in a matrixed or global environment.

Knowledge Areas

Pharmaceutical Manufacturing & CMC - Deep knowledge of GMP operations, validation, and regulatory frameworks.

Digital Transformation Trends - Awareness of emerging technologies, automation, and data analytics in operations.

Governance & Risk Management - Familiarity with enterprise governance structures and risk mitigation strategies.

Performance Management Systems - Expertise in KPI development, dashboarding, and performance analysis.

Organisational Development - Understanding of capability building, leadership development, and team performance management