Senior Manager - MSAT / Production (Pharma)

Helsinn Birex Pharmaceuticals Ltd.; Dublin; On-site; EUR 120,000 - 160,000; Full time

Job summary

Helsinn Birex Pharmaceuticals Ltd. seeks an experienced Senior Manager - MSAT / Production to lead manufacturing and packaging operations in a GMP-regulated environment.

You will drive operational excellence, collaborate with Quality, Engineering and MSAT to ensure regulatory compliance and on-time delivery of products. The role reports to the Manufacturing, Science and Technology Director and involves strategic and hands-on leadership across manufacturing, process validation and technology

Qualifications

• 8–10+ years in pharmaceutical manufacturing under GMP.
• Experience leading MSAT activities and technology transfer.

Responsibilities

• Lead daily manufacturing and packaging operations to meet targets and quality standards.
• Provide strategic leadership for site manufacturing and technical roadmaps.
• Drive Lean/Six Sigma initiatives to improve yield and reduce waste.

Skills

MSAT

Lean/Six Sigma

GMP

OSD

Process Validation

Education

Pharmaceutical Science/Chemistry/Biotechnology degree

Related technical discipline

Tools

ERP systems

MES systems

Job description

Helsinn Birex Pharmaceuticals is currently seeking an experienced Senior Manager - MSAT / Production to lead and optimise our manufacturing operations within a GMP-regulated environment.

Reporting to the Manufacturing, Science and Technology Director, this role will provide strategic and operational leadership across manufacturing and packaging operations, ensuring the achievement of production targets, regulatory compliance, quality standards and business objectives.

Key Responsibilities:

• Lead and manage daily manufacturing and packaging operations to ensure production targets, quality standards and timelines are achieved.
• Provide strategic leadership for site manufacturing operations and contribute to the development and execution of the site's operational and technical roadmap.
• As the Production SME on the OPEX Fusion Team, drive Operational Excellence / Lean / Six Sigma initiatives identified to improve yield, reduce waste, increase efficiency and optimise process flow.
• Monitor production performance through KPIs, report results through the site's Metrics Programme, analyse trends and implement corrective and preventive actions.
• In collaboration with Supply Chain Operations, manage production scheduling, capacity planning and resource allocation.
• Collaborate closely with Quality, Engineering, Maintenance, Supply Chain and MSAT functions to ensure compliance with cGMP and operational requirements.
• Oversee deviation management, root cause investigations, risk assessments and implementation of CAPAs.
• Serve as the Manufacturing lead for New Product Introduction (NPI), Process Validation and Technology Transfer programmes, ensuring successful implementation and commercial readiness.
• Provide technical leadership and support for the development, validation and commercialisation of new pharmaceutical products.
• Lead and support technology transfer activities for new and existing products, ensuring robust process understanding, operational readiness and successful execution within the manufacturing environment.
• Partner closely with MSAT to support process development, process scale-up, process validation and continued process verification activities.
• Ensure successful execution of process validation and cleaning validation programmes in accordance with regulatory expectations and company standards.
• Collaborate with Analytical Development and Quality Control functions to support the development, validation and transfer of analytical methods required for product development, process validation and commercial manufacturing.
• Provide technical oversight and support on all aspects of analytical development relevant to manufacturing processes and product lifecycle management.
• Support product lifecycle management activities, continuous process improvement initiatives and technical investigations.
• Lead, develop and coach a high-performing team, including supervisors and production personnel, ensuring appropriate training, succession planning and performance management.
• Drive employee engagement initiatives and foster a culture of accountability, collaboration and continuous improvement.
• Participate in regulatory inspections, customer audits and internal audits, ensuring a constant state of inspection readiness.
• Contribute to budget planning, cost control, capital investment projects and long-term operational planning.
• Prepare and present operational, technical and strategic updates to senior leadership teams.

Required Qualifications and Experience:

• Third-level qualification in Pharmaceutical Science, Chemistry, Biotechnology or a related technical discipline.
• Minimum of 8–10 years' experience within a pharmaceutical manufacturing environment operating under GMP regulations (EU GMP, HPRA, FDA and other applicable global standards).
• Strong practical experience in Manufacturing Science & Technology (MSAT) activities including process development, process optimisation, scale-up and lifecycle management.
• Strong technical knowledge of pharmaceutical manufacturing processes, process validation, technology transfer, deviation management and quality systems.
• Experience supporting the development, validation and transfer of analytical methods within pharmaceutical manufacturing and/or technical operations environments.
• Significant leadership experience managing manufacturing teams within a regulated pharmaceutical environment.
• Demonstrated experience supporting or leading the development, validation and commercial introduction of new pharmaceutical products.
• Proven experience leading or supporting technology transfer projects within pharmaceutical manufacturing operations.
• Experience supporting process validation, cleaning validation and continued process verification programmes.
• Strong understanding of product development, commercialisation and lifecycle management principles.
• Experience with ERP and/or MES systems.
• Experience within Oral Solid Dose (OSD) manufacturing is highly desirable.
• Experience in aseptic or sterile manufacturing environments would be advantageous.
• Demonstrated success in Continuous Improvement, Operational Excellence, Lean Manufacturing and/or Six Sigma initiatives.
• Strategic leadership and organisational development capability.
• Strong technical and scientific expertise in pharmaceutical manufacturing and MSAT activities.
• Ability to lead complex cross-functional initiatives including NPI, Process Validation and Technology Transfer programmes.
• Excellent stakeholder management and influencing skills.
• Strong business acumen and decision-making capability.
• Exceptional problem-solving and analytical skills.
• Strong project management and prioritisation skills.
• Excellent communication and presentation skills.
• Strong understanding of GMP, EHS and regulatory compliance requirements.
• Continuous improvement mindset with the ability to drive innovation and operational excellence.
• Ability to build, develop and inspire high-performing teams.