Amy Mess

• Lead a 26-member Marketing Operations team, including 3 senior managers, overseeing commercialization, communications, and packaging execution across 13 brands.
• Architected and scaled the North American Stage Gate process, managing a portfolio of ~250 innovation and renovation projects across four business units.
• Spearheaded digital transformation initiatives, including Smartsheet deployment and process automation, enhancing speed and efficiency.
• Directed enterprise-wide initiatives including a $40MM structural cost-saving program and a cross-border business process alignment yielding $4MM in savings.
• Led transformation of enterprise planning processes, technologies, and roles in partnership with external consultants.

• Directed high-priority FDA remediation teams to facilitate resumption of halted manufacturing operations.

Implemented robust restart strategies, incorporating retrospective QbD assessments and comprehensive regulatory analysis.

Created product-specific regulatory scenario decision trees for informed marketing and financial planning decisions.

Managed development of detailed restart timelines with consistent weekly reporting and issue escalation processes.

• Executed analytical R&D and quality control initiatives, including method transfers and laboratory readiness assessments.
• Spearheaded factory restart efforts by improving plant processes and modifying existing systems.
• Facilitated packaging restart activities through engineering batch production and validating facility readiness.
• Oversaw all communications regarding timelines and project updates across company levels.

Managed pipeline of over 20 generic product projects, prioritizing first-to-file opportunities.

Led cross-functional teams through all phases of product development from concept to launch.

• Developed timeline template for internal team to enhance new product development processes.

• Directed global Phase III tech transfer initiatives across cell culture, purification, and analytical domains.
• Oversaw GMP readiness and facility certification for new product suites.

Led multi-site, cross-functional teams in Phase III technology transfer projects.

Facilitated domestic and international transfer of Phase III products.

Managed project communication and escalation to local and corporate CMC leadership.

Supervised cGMP readiness assessments for sites and certifications of suites/facilities.

• Guided cell culture, purification, and analytical sub-teams to meet objectives.
• Coordinated changeovers for new product suites and equipment.

• Delivered global compliance systems aligned with CFR 21 and consent decree timelines.
• Designed and implemented SCI training and multi-site rollout strategies.