PURPOSE:

• Provide strategic leadership and oversight for the Manufacturing Support function supporting biologics operations, including cell culture, media and buffer preparation, and purification.
• Lead the team in driving training excellence, nonconformance investigations, quality, process improvement, change control execution, and SOP governance while ensuring compliance, safety, operational readiness, and technical capability across the organization.
• Serve as a key cross-functional partner to manufacturing operations, quality, technical operations, and site leadership in delivering reliable, efficient, and inspection-ready operations.

MAJOR RESPONSIBILITIES:

Operational and Technical

• Lead and/or sponsor manufacturing related projects and site initiatives across biologics operations, including cell culture, media and buffer preparation, purification, process improvement, and inspection readiness activities
• Serve as manufacturing representative/lead for new product introductions transferred to the site, ensuring end-to-end execution of manufacturing deliverables, milestones, and launch readiness requirements as governed per change plan.
• Set project direction, priorities, and execution strategy for time-sensitive manufacturing deliverables, to ensure schedule adherence, quality, and operational readiness are met.
• Provide leadership for cross-functional planning, issue resolution, and escalation for manufacturing related projects, non-conformance investigations and change plans, ensuring risks, dependencies, and resource needs are addressed proactively.
• Report project progress, key risks, and decisions to senior management and above-site leadership, providing clear recommendations and visibility to support governance and decision-making.
• Drive change controls, process improvements, and implementation activities required to support product introductions, technical changes, and operational readiness.
• Analyze data, trends, and manufacturing insights to identify opportunities to improve process robustness, efficiency, and right-first-time execution.
• Evaluate the operational and technical impact of changes and partner with cross-functional stakeholders to ensure successful implementation.
• Provide oversight of biologics facility cleaning supervisors and cleaning operations to ensure compliant, effective, and timely execution of cleaning activities that support manufacturing readiness, contamination control, and site operational requirements

Quality

• Lead complex nonconformance and incident investigations, ensuring robust root cause analysis, CAPA development, and effective closure.
• Ensure compliance with cGMP, quality system requirements, and site procedures in all support activities.
• Support inspection readiness, audit responses, and regulatory compliance through disciplined documentation and issue management.
• Trend Key Performance indicators, quality events and recurring issues to identify systemic risks and implement measures to streamline work processes and procedures.

Training

• Own the training strategy for biologics operations, including Master Trainer and related training programs.
• Lead team to develop, improve, and maintain technical training programs for biotechnologists supporting cell culture, media and buffer preparation, and purification operations.
• Lead team to assess training effectiveness and implement improvements to strengthen capability and performance.

People and Culture

• Lead, coach, and develop the Manufacturing Support team to build capability, accountability, and engagement.
• Set expectations, provide feedback, and support performance management, development planning, and succession planning.
• Foster a culture of ownership, collaboration, continuous learning, and quality mindset across the team.
• Build strong cross-functional relationships and influence stakeholders to achieve shared business goals.