Associate Director, Global MSAT (Cell & Gene Therapy)

Lonza • Portsmouth, NH

17d • Onsite

About The Position

Associate Director, Global MSAT (Cell & Gene Therapy) Location: On-site, Portsmouth, NH. Relocation assistance is available for eligible candidates and their families. The Associate Director, Global MSAT (Senior Product Steward) will serve as the technical lifecycle owner for assigned Cell & Gene Therapy products, ensuring robust, compliant, and reliable manufacturing performance across Lonza’s global network. The role will lead global product lifecycle management, lead multi site governance and process monitoring, while driving continuous improvement and innovation. It will also provide expert technical support, ensure regulatory and change management alignment across sites, and collaborate closely with cross functional teams to maintain consistent product performance and strong customer satisfaction. The position provides flex support to augment site technical capabilities and to drive delivery. What you will get: A collaborative and inclusive work environment. Opportunities for career growth and development. Access to cutting-edge technologies and tools. Competitive compensation and benefits package. 401(k) matching plan. Supportive leadership and mentoring. Commitment to ethical and sustainable practices. Access to our full list of global benefits: https://www.lonza.com/careers/benefits

Requirements

• Bachelor’s Degree required in a field of study such as Chemical Engineering, Biochemical Engineering, Biomedical Engineering, Biotechnology, or other life science degree with 12-15 years’ experience within the bio/pharma industry or Master’s Degree with 10-13 years’ experience.
• In-depth understanding of TrackWise functionality.
• Comprehensive understanding of New Product Introduction (NPI) and Process Lifecycle stages.
• Experience with Root cause analysis, Gap assessments, FMEA and risk assessments.
• Identifying and escalating risks early in the process, suggesting mitigation actions.
• Sterility Assurance (material quality attributes, aseptic interventions, Aseptic Process Simulation, facility and equipment, Grade A / B allowances and restrictions).
• This position is remote with up to 20% travel (domestic and international).

Responsibilities

• Global Technical Ownership: Serve as the lead technical owner for multi-site manufacturing to align process performance, control strategies, and lifecycle management.
• Cross-Site Governance: Lead technical forums to standardize knowledge, deviations, CAPAs, and change management across all operating sites.
• Performance Monitoring: Coordinate multi-site Continued Process Verification (CPV) and data reviews to ensure harmonized monitoring and consolidated reporting.
• Risk Mitigation: Monitor Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs) to identify risks, process drifts, or atypical trends and proactively drive resolutions.
• Variability Resolution: Identify root causes for site-to-site variability and implement unified corrective and preventive actions.
• Regulatory & Quality Support: Provide scientific rationale for Health Authority queries and ensure consistency in regulatory submissions and comparability packages.
• Stakeholder Management: Act as the primary interface between global teams (MSAT, QA, QC, Ops) and customers to align requirements and communicate improvement initiatives.

Benefits

• A collaborative and inclusive work environment.
• Opportunities for career growth and development.
• Access to cutting-edge technologies and tools.
• Competitive compensation and benefits package.
• 401(k) matching plan.
• Supportive leadership and mentoring.
• Commitment to ethical and sustainable practices.
• Access to our full list of global benefits: https://www.lonza.com/careers/benefits

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level