Provide end-to-end quality oversight to validation, tech transfer, digital systems, and facilities and engineering across the Global Drug Substance Network. •Lead the Quality Engineering function, ensuring cohesive support across all DS manufacturing sites.•Oversee quality for the DS network in new product introductions, technology transfers, and validation activities, ensuring alignment with regulatory, industry, and internal standards.•Standardize quality processes across the DS manufacturing sites to ensure consistent quality assurance expectations for tech transfer and validation, inclusive of facility, utility, and equipment commissioning and qualification, and computer system validation. •Represent Quality Engineering in global cross-functional forums, supporting oversight of manufacturing and testing facilities, and collaborating with MST, Digital, Facilities and Engineering, Product Quality Leads, Quality Control, and Regulatory.•Develop policies and procedures supporting Commissioning, Qualification, and Validation (CQV), promoting continuous improvement and innovation while compliant with international GxP standards.•Drive improvements across sites to reduce costs, cycle time, and deviations, while supporting operational excellence.

Accountable for ensuring the highest standards of quality and compliance in Validation, Tech Transfer, Digital Systems, and Facilities and Engineering at the Norwood Campus. Responsibilities include:•Develop and implement quality engineering strategies, policies, and procedures to ensure compliance with regulatory requirements, industry standards, and best practices.•Oversee the validation activities related to manufacturing processes, equipment, and systems to ensure compliance with regulatory requirements and quality standards.•Establish and maintain a comprehensive facilities quality program, including the development and implementation of policies, procedures, and guidelines.•Provide quality oversight and guidance for the tech transfer process of mRNA therapeutics from research and development to clinical drug substance and clinical drug product manufacturing.•Collaborate with IT, F&E, and Digital to leverage AI and machine learning to support predictive maintenance, anomaly detection, and risk assessment.

• Act as leader and single point of contact for Moderna’s US Contract Manufacturing Organizations to ensure on-time and in-full deliveries. Partner with Supply Chain, Procurement, Quality, and Technology/Development on all aspects of the relationships with the CMOs.• Accountable for ensuring that all operational-related activities at the CMOs are conducted to meet Moderna’s requirements (Compliance, Meeting Orders, Dispute Resolution, Production Planning, Materials Management, Technology Issues, OpEx). • Ensure that externally manufactured products are produced and stored according to the appropriate documentation in order to obtain the required quality.

• Responsible for ensuring daily operational excellence across the Technical Development organization. • Assembled and led a high-performing team, consisting of managers and engineers, to develop and facilitate execution of Technical Development business operations. • Built and improved on adaptable and lean business processes to support Moderna’s development pipeline, enabling clear communication, prioritization, and escalation within and external from Technical Development. • Responsible for development, adherence, and reporting of Technical Development budget, including direct oversight of capital, consumables, external spend, and headcount allocation. • Facilitated Technical Development leadership and management governance.

• Served as subject matter expert on complex aseptic filling applications for both internal and external manufacturing operations, including container closure integrity, sterilization, and visual inspection. Equipment included state-of-the-art, highly automated systems, as well as traditional, legacy systems. • Facilitated fill finish site and line startup on tight timelines with multiple contract manufacturing organizations in both liquid and lyophilized presentations.• Managed Drug Product Pilot Operations group (4 engineers) simultaneously with the Sterile Product Technology group (2 engineers). Groups were responsible for all pilot and toxicology drug product batch manufacture, as well as tech transfer and oversight of all Moderna fill finish operations. • Consulted on the selection, design, implementation for all aseptic fill/finish processes in the Moderna Clinical Manufacturing Facility (Winner of the ISPE 2019 Facility of the Future award).• Ensured that assigned processes are cGMP compliant and were designed to meet the regulations of the U.S FDA and the EMEA. Authored and reviewed regulatory submissions sections related to drug product development and container closure.

• Grew and develop the Process Engineering group, a staff of 8 comprised of chemical and biomedical engineers, a biologist, and a technical writer. • Contributed to the cross-contamination risk assessment and FMEA run by Stephane and Julian Wilkins and performed in accordance with ICH Q9 and ISPE Baseline Guide 7, Risk Based Manufacture of Pharmaceutical Products (RiskMAPP). • Championed complex particulate, content uniformity, and bioburden OOS departure investigations utilizing techniques such as 5 Whys, Fishbone Diagrams, Failure Mode Analysis, and Process Capability Analysis. Implement specific, quantifiable, and effective CAPA plans.• Performed failure mode and effect analysis (FMEA) on multiple registration phase production processes in support of Process Qualification per PDA TR 60.• Created process validation protocols, reports, and protocol discrepancies for commercial manufacturing processes.

• Led members of the Process Engineering group in the tech transfer of client projects. Activities included feasibility studies, equipment design and qualifications, batch record creation, process validation, and departure reports.• Increased the Technical Operations group's role in continuous improvement projects, investigations, and training of Manufacturing personnel. Interfaced with Process Engineering to transfer processes to the Manufacturing department.• Led a cross-functional team in the development of a complex aseptic formulation, including sterile microfluidization, sampling, suspension uniformity challenges, and lyophilization.• Oversaw the specification and design process for the site’s Aseptic / Potent Compounding Isolator per PDA TR 34.• SME on Sterilizing Filter Validation per PDA TR 26

• Developed, scaled-up, qualified, and implemented aseptic cGMP manufacturing processes for commercial registration of a controlled-release oncology product, including CIP, SIP, aseptic connections, buffer preparation, sterile filtration, aseptic filling, and visual inspection.• Lead in the tech transfer of client processes and execute engineering functions including design and document controls. Identify and specify process specific equipment needed for client tech transfer.

• Jointly designed, installed, qualified, and operated pilot scale production skids from 5L to 50L working volumes.• Established myself as the lead resource in Baxter MTD for lyophilization technology. Created, modified, and optimized freeze drying cycles tailored to specific product requirements.• Developed, scaled-up, qualified, and implemented aseptic manufacturing processes, including CIP, SIP, buffer preparation, ultrafiltration, microfiltration, sterile filtration, centrifugation, and lyophilization.• Authored and reviewed process development and manufacturing protocols, reports, SOPs, and pre-clinical and clinical batch records.