Director, Technical Operations

A brief overview

The Director, Technical Operations leads the Technical Operations team and ensures that manufacturing technology, technical capabilities, and operational readiness support site objectives, customer requirements, regulatory expectations, and global standards. This role provides leadership for technical operations across manufacturing support, technology transfer, product stewardship, process optimization, validation support, automation and digitalization initiatives, technical documentation, and lifecycle management activities. The Director, Technical Operations leads scientists, chemists, engineers, technical writers, process specialists, and other technical experts supporting clinical and commercial manufacturing, new product introductions, and technology transfers. The role collaborates closely with Manufacturing, Quality, Engineering, Supply Chain, R&D, Project Management, and Global Technical Operations to strengthen process robustness, inspection readiness, operational excellence, and future site capabilities. This position reports to the Vice President, Global Technical Operations.

What you will do

• Ensure technical support for clinical and commercial products through technology transfer, process monitoring, troubleshooting, product stewardship, validation support, lifecycle management, and manufacturing readiness activities.
• Lead technology transfer activities, including internal transfers and transfers from client sites, ensuring effective planning, risk assessment, process understanding, validation readiness, and technical documentation.
• Lead efforts to improve manufacturing efficiency and process robustness through troubleshooting, root cause investigations, change controls, CAPAs, data analysis, and process optimization initiatives.
• Serve as a member of the site leadership team, representing Technical Operations in site initiatives, operational readiness activities, and alignment with global technical standards.
• Lead technical support for manufacturing activities, new product introductions, process improvements, and site operational initiatives in partnership with Manufacturing, Quality, Engineering, Supply Chain, R&D, and Project Management.
• Support the development and implementation of technical capabilities, automation and digitalization initiatives, and platform technologies aligned with site and business needs.
• Coach, develop, and retain technical talent by promoting knowledge sharing, continuous improvement, accountability, and professional development.
• Partner with cross-functional stakeholders to support technical strategies, risk management activities, technology transfer execution, operational excellence initiatives, and COGS improvement efforts.
• Support regulatory inspections, audits, validation activities, and inspection readiness efforts by providing technical expertise and documentation support.
• Promote process safety, technical stewardship, and compliance with company policies, procedures, and GMP requirements.

Qualifications

• Bachelor's Degree in Chemical Engineering, Biochemical Engineering, Pharmaceutical Sciences, Chemistry, or a related scientific or engineering discipline with equivalent relevant experience or
• Master's Degree in Chemical Engineering, Biochemical Engineering, Pharmaceutical Sciences, Chemistry, or a related scientific or engineering discipline
• 8+ years of GMP experience in pharmaceutical, biotech, CDMO, process development, manufacturing science, technical operations, or manufacturing environments with exposure to clinical and commercial manufacturing.
• 3+ years of leadership experience in Technical Operations, manufacturing science, process development, or related technical functions, including leadership of technical and cross-functional teams, technology transfers, process optimization, validation support, technical documentation, and lifecycle management activities.
• Strong knowledge of GMP, quality systems, regulatory requirements, validation principles, process safety, and inspection readiness expectations.
• Strong analytical, troubleshooting, decision-making, and problem-solving skills; familiarity with Lean Six Sigma and operational excellence methodologies.
• Ability to lead and develop technical teams and effectively collaborate with cross-functional stakeholders.
• Strong project management and communication skills with the ability to influence stakeholders and drive execution.
• Understanding of budgeting, resource planning, COGS improvement opportunities, and business considerations that impact Technical Operations.
• Ability to work effectively within a matrix organization and collaborate across multiple functions and sites.
• Demonstrated ability to lead change, improve processes, and support implementation of new technologies and digital tools.
• Strong technical understanding of manufacturing processes, equipment, technology transfer, product stewardship, lifecycle management, SOPs, qualification protocols, ERP/MES systems, and technical documentation.