Sara J. Miller

(Previously Assoc. Director, New Product Introductions (Apr. 2022 - Jun. 2022)

• Responsible for the development of the growth strategy for each Cell Therapy Service Offering
• Collaborate with Strategic Business Development partner to assemble and present market and situational analysis data to support the growth of the business strategy
• Review, collate and report operational and financial performance data for the Cell Therapy Service Offering
• Track strategic projects sanctioned for Cell Therapy, to enable product or service launch working with the global marketing team
• Lead the cross-functional Business Steering Group for the Cell Therapy offering, ensuring representation and participation of critical roles such as marketing, strategy, commercial and technical development

• Lead and support Manufacturing network development for processes and systems
• Lead new product introduction, facility modification, and other complex, cross-functional, and high visibility projects
• Identify and mitigate risks in manufacturing operations that could negatively impact delivery of safe and effective therapies to patients
• Partner with Manufacturing, Supply Chain, and Quality teams to identify and drive process optimization initiatives and address opportunities for efficiency and capacity improvements in all areas of internal and external manufacturing

• Responsible for Quality support and oversight for Technology Transfer of Phase I, II, and III autologous and allogeneic gene therapy products
• Establish US and EU compliant and innovative solutions to serve unique client needs with a patient-focused approach
• Successful execution of improvement projects that impact multiple client processes and product to improve overall quality of output and reduce lead time
• Effective development of strategies for integration of client requirements into Cognate QMS based on review of Master Service Agreements, Quality Agreements and dynamic, evolving product requirements

• Efficiently utilized Lean principals and project management tools to reduce lead times in batch product record review and disposition by 15%, raw material release (from 3 weeks to 5 days), and environmental monitoring documentation from 2 weeks to 3 days
• Onboarded new clients into Quality Systems: engaged with equivalent client QA leadership to review batch record development, disposition processes, and non-conformance pathways
• Effectively developed and onboarded QA Specialists: enhanced client-facing skills, provided opportunities for cross-functional interactions, and offered technical writing training and feedback
• Successfully directed client and regulatory body audit preparations and backroom support to deliver audit requests in a timely manner and prepare subject matter experts

• Implemented improvements using Value Stream Maps, SIPOC, and customer feedback
• Effectively organized and facilitated improvement events with cross-functional teams
• Provided weekly status updates to site and corporate leadership
• Successfully utilized strategic thinking and coordination with sister sites to standardize and improve best practices universally

• Efficiently facilitated, educated and coached over 350 employees in value stream integrated process teams using Lean principles and systems thinking
• Transitioned developing teams including Aseptic and CAPA integrated systems teams to be efficient in highly regulated markets
• Spearheaded a site-wide 5S program by empowering core team members to use PDSA cycles thereby implementing improved standards, increased participation at all levels, and expanded 5S to office operations and electronic systems
• Created and executed studies using QbD and Lean principles to improve manufacturing processes by increasing product yield by 5% and identify comparable redundancies to support business continuity goals
• Cultivated a continuous improvement culture in a legacy manufacturing facility

Previous roles in this company included Process Development Associate Scientist and Manufacturing Specialist. These roles supported the cGMP production and investigational improvement of the commercial vaccine Anthrax Vaccine Adsorbed or Biothrax.