EMMA BOLTON
Summary
Multi-scoped Operations Professional with a strong focus on enhancing efficiency through decisive leadership, and strategic decision-making. Areas of expertise include Quality Assurance, Manufacturing Operations, Global Supply Chain, and Supply Chain Operations. Proven track record in process optimization and transformational leadership across Technical Operations. Co-chair of the BioMarin Women's Alliance, leading development and support opportunities for over 500 members.
Overview
17
17
years of professional experience
1
1
Certification
Work History
Associate Director, Supply Chain Operations
BioMarin, Inc
01.2023 - Current
- Senior Manager 2023-2024, promoted to Associate Director in 2024.
- Lead GMP purchasing, inventory control, 3PL management, and ERP Data & Recipe Management for Novato Operations.
- Oversee $100M raw materials spend with focus on optimizing inventory and reducing waste.
- Lead the L2 Value Commitment Pillar for Raw Material Inventory Optimization, driving measurable improvements in supply chain operations across the network.
- Accountable to NLT and site governance for monthly financial cost review.
- Developed and implemented comprehensive Raw Material Purchasing and Raw Material Scrap Strategies, significantly reducing waste and achieving more than $15M in cost savings.
- Coordinated with 3PL partners to integrate and streamline logistics operations, resulting in improved service levels and reduced lead times.
- Identified external partner consolidation opportunities and led reduction of the overall 3PL footprint to achieve ~$1M in cost savings.
- Fostered a culture of teamwork and accountability within the Supply Chain Operations team, improving employee engagement and measurable performance improvements.
- Analyzed raw material usage patterns to refine inventory strategies, leading to notable cost savings and substantial improvements in supply chain efficiency.
Product Launch Manager Product Supply Chain
BioMarin, Inc
01.2021 - 01.2023
- Responsible for the successful commercial launch of VOXZOGO in EU, US, and Japan, as well as other minor markets. I also supported launch activities for Palynziq and Kuvan.
- Responsible for leading and coordinating workstreams from cross-functional teams of 10-15 functional leaders who were responsible for planning and execution of market level product launches.
- Coordination with PQLs and CMC on pre-launch product testing strategy
- Provided coaching and development to team members on project and launch management methodologies, measured performance of team members to achieve deliverables, and provided feedback to functional management on team members’ overall performance and development needs.
- Applied project management expertise, methodologies, and standards to manage launches and packaging lifecycle changes for multiple product lines.
- Executed strategic product launches across multiple global regions to achieve timely market entry and enhance market penetration.
- Leveraged well developed interpersonal skills to build and maintain positive working relationships with key stakeholders.
- Develop tools and metrics to use across product lifecycle changes and launches.
Manager, Manufacturing
BioMarin, Inc
01.2020 - 01.2021
- Managed a multi-level manufacturing team and was responsible for coordination of staff, operations, equipment, environment, and logistics in the Galli East manufacturing facility.
- Oversaw and directed the development, implementation, and maintenance of manufacturing methods, processes, equipment, and operations for commercial drug substance production.
- Oversaw the Process Team and its functional members in a matrix reporting structure, applied performance data to evaluate and improve operations and business conditions, forecast needs, and responded to all frontline issues.
- Worked closely with Technical and Quality groups to ensure strict compliance with Good Manufacturing Practices.
- Monitored and supported workforce development for my functional area.
- Oversee the execution of manufacturing policies, procedures, campaigns, and programs.
- Selected, developed, and evaluated personnel to ensure performance, delivery, and longevity within our workforce.
- Utilized performance metrics to identify bottlenecks and implement targeted strategies to improve productivity.
- Managed operational constraints due to 2020 covid-related issues such as material diversion for vaccine development, restrictions to personnel activity, and using unfamiliar ways of working and communicating.
Manager, Quality Assurance Operations
BioMarin, Inc
01.2018 - 01.2020
- Managed a team of professionals responsible for providing oversight of Quality Operations for my functional area, including review of documentation, change control, deviation/CAPA management, QC record review, product changeover oversight, and execution of Lot Release.
- Facilitated Drug Substance Quality management of commercial and clinical product launches, domestic and EU.
- Stabilized a manufacturing facility in transition from clinical to commercial operations (Palynziq and VOXZOGO).
- Ensured adherence to company policies/procedures, regulatory licenses, Quality and Technical agreements, industry standards, and cGMP regulations.
- Provided continuous Quality support and oversight to QC, Facilities, Materials Management, and Manufacturing Operations
- Drove on-time execution of record closure in Quality Management Systems and releasing of lots to meet both Supply Chain and Quality timelines
- Maintained and continuously improved Quality Management Systems and Programs
- Maintained a state of inspection readiness for MFG and QA
- Fostered a culture of continuous improvement, mentoring team members on quality practices to enhance overall team performance and engagement.
Associate I & II, Quality Assurance Operations
BioMarin, Inc
01.2017 - 01.2018
- Provided Quality oversight of deviations and change controls to ensure compliance in drug manufacturing processes.
- Reviewed GMP master documents and executed batch records for accuracy and operational efficiency.
- Performed QC record review and DS lot release, ensuring timely delivery and product integrity.
Quality Specialist, Manufacturing
BioMarin, Inc
01.2016 - 01.2017
- Led investigations for drug manufacturing deviations, enhancing compliance and safety.
- Resolved quality issues, improving production efficiency and reliability.
- Collaborated with cross-functional teams to ensure adherence to regulatory standards.
Quality Assurance Associate I & II
Genentech, Inc
01.2011 - 01.2013
Sterile Filling Technician
Genentech, Inc
01.2009 - 01.2011
Education
Bachelor of Arts - Cell and Molecular Biology, with Honors
Mills College
Oakland, CA05.2016
Certification
- Python Data Analysis Certificate eCornell 2022
- Executive Leadership Certificate eCornell 2022
- Performance Leadership Certificate eCornell 2022
- Project Management Certificate eCornell 2022
Affiliations
- Caryl Parker Haskins Prize for Distinction in the Life Sciences - Mills College, 2016
- Vanity Fair Magazine Interviewee, May 2016
- Member, Professional Businesswomen of California (PBWC)
- Member, BioMarin PRIDE Employee Resource Group
- Co-Chair, BioMarin Women’s Alliance
Timeline
Associate Director, Supply Chain Operations
BioMarin, Inc
01.2023 - Current
Product Launch Manager Product Supply Chain
BioMarin, Inc
01.2021 - 01.2023
Manager, Manufacturing
BioMarin, Inc
01.2020 - 01.2021
Manager, Quality Assurance Operations
BioMarin, Inc
01.2018 - 01.2020
Associate I & II, Quality Assurance Operations
BioMarin, Inc
01.2017 - 01.2018
Quality Specialist, Manufacturing
BioMarin, Inc
01.2016 - 01.2017
Quality Assurance Associate I & II
Genentech, Inc
01.2011 - 01.2013
Sterile Filling Technician
Genentech, Inc
01.2009 - 01.2011
Bachelor of Arts - Cell and Molecular Biology, with Honors
Mills College
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