Senior MSAT Director

MSAT Senior Director

The MSAT Senior Director will lead the strategic and operational direction of the MSAT function at WuXi Biologics commercial drug substance manufacturing facility in Dundalk. This role is pivotal in ensuring the

robustness scalability and compliance of biologics manufacturing processes across the product lifecyclefrom late-stage tech transfer through commercial supply. The incumbent will oversee a multidisciplinary team responsible for process validation lifecycle management technical investigations and continuous improvement. This leader will serve as a key interface between global technical functions regulatory affairs quality and manufacturing ensuring alignment with global standards and regulatory expectations.

Organization Description
WuXi Biologics is a premier provider of biologics services (from discovery to commercialization) with global customers in the biopharmaceutical and healthcare industries. Were one of the worlds top three contract development and manufacturing companies for biopharmaceuticals we provide our clients with a world-leading open access technology platform. Our mission is to accelerate and transform discovery development and manufacturing in the rapidly growing field of biologics to benefit patients worldwide.

Department Description

As MSAT Senior Director youll be joining an organization where people of all backgrounds and experiences are respected and where we work together focused on changing this role you will report to the Ireland Site Head and VP of Manufacturing.

Your Responsibilities:

Strategic Leadership

• Define and execute the MSAT strategy aligned with site and global manufacturing goals.
• Lead the development and implementation of process lifecycle management strategies for commercial Biologics.
• Represent MSAT in global governance forums regulatory inspections and customer engagements.

Operational Excellence

• Oversee all aspects of process validation (PPQ CPV) technology transfer and process performance monitoring.
• Drive a culture of data-driven decision-making leveraging statistical tools and digital platforms.
• Ensure robust deviation management root cause analysis and implementation of effective CAPAs.

Technical Oversight

• Provide subject matter expertise in upstream and downstream biologics manufacturing.
• Lead complex technical investigations and process optimization initiatives.
• Oversee the operation and strategic direction of the MSAT laboratory ensuring alignment with commercial needs.
• Ensure following the requirements of EudraLex cGMP and all other applicable regulatory guidelines.

People & Team Development

• Build and mentor a high-performing MSAT team with strong technical and leadership capabilities.
• Foster a culture of collaboration accountability and continuous learning.
• Ensure clear roles responsibilities and development pathways for team members

Cross-Functional Collaboration

• Partner with Manufacturing Quality Regulatory Analytical Sciences and Global MSAT to ensure seamless execution of commercial operations.
• Support regulatory submissions inspections and audits with high-quality technical documentation and responses.
• Will be flexible to take on additional tasks and responsibilities at the discretion of the Site Lead and Vice President.
• Will act as a role model for the MSAT function and also the wider organisation in adherence to the WuXi corporate core values and PROUD culture

Your Profile: The ideal candidate for this position will have the following:

Education:

• Ph.D. or M.S. in Biochemical Engineering Biochemistry or related scientific discipline.

Knowledge/Experience:

• 15 years of experience in biologics manufacturing with at least 5 years in a senior leadership role within MSAT or Technical Operations.
• Proven track record in commercial-scale technology transfer process validation and lifecycle management.
• Demonstrated success in leading cross-functional teams and managing complex technical programs.
• Experience supporting global regulatory submissions (e.g. BLA MAA) and inspections (FDA EMA
• Deep expertise in mammalian cell culture and downstream purification processes.
• Strong understanding of cGMP ICH guidelines and global regulatory expectations.
• Proficiency in statistical analysis tools (e.g. JMP Minitab) and process monitoring systems.
• Familiarity with digital manufacturing tools and data analytics platforms is a plus.

Behavioural Competencies:

• Strategic thinker with strong business acumen.
• Exceptional leadership communication and stakeholder management skills.
• Ability to influence across functions and geographies.
• High level of integrity accountability and resilience

Other requirements:

• Must be willing to travel as required internationally to fulfil the responsibilities of the position.

Dont miss out on this opportunity to join us and reach beyond yourself and discover your true potential. Apply now! Would you like to know more before you apply Please visit us at

WuXi Biologics is an equal opportunities employer.