The Biologics Technical Operations Scientist provides advanced technical and engineering leadership, along with program management support, to biologics manufacturing operations on site. This role is accountable for sustaining existing biologics products, resolving complex technical challenges, ensuring compliance with regulatory and quality expectations, and driving continuous improvement through innovative process enhancements, improved controls, and robust execution across the manufacturing lifecycle.

Major Responsibilities

• Provide hands-on technical leadership to Production Team Leaders to optimize process performance, improve equipment reliability, and resolve complex manufacturing issues.
• Lead process development activities for existing products including tech transfer and successful scale-up to plant equipment.
• Develop and implement process controls to optimize commercial manufacturing processes and strengthen process robustness.
• Design and refine process control for the continuous improvement of existing commercial processes.
• Manage process improvement projects from initiation through execution, ensuring delivery against scope, timeline, budget, quality expectations, and regulatory requirements.
• Support and uphold all EHS standards, procedures, and policies, promoting a strong culture of safety and compliance.
• Lead root cause analysis investigations for process non-conformances and develop effective, sustainable CAPAs in alignment with regulatory expectations.
• Design and execute pilot-scale manufacturing DOE studies to generate development packages and support technical decision-making.
• Provide technical support for commissioning and validation activities throughout project execution.
• Ensure compliance with all applicable Corporate, Divisional, quality, and regulatory policies, procedures, and requirements.