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Description

Given the current environment of global supply chain challenges affecting daily lives from retail to technology, the biotechnology industry is no different in experiencing raw materials delays and shipping drug substance for further processing before our therapies get to our patients. This course is recommended for Supply Chain staff, R&D Managers, and anyone with an interest in how supply chains work in the Biopharma industry.

Schedule

1. Monday, September 18th, 2023, 10:00 AM – 12:30 PM EST
2. Thursday, September 21st, 2023, 10:00 AM – 12:30 PM EST
3. Monday, September 25th, 2023, 10:00 AM – 12:30 PM EST

Agenda

Session 1:

• Supply Chain Overview
• Compliance Considerations and Requirements
• What is GMP?

Session 2:

• Tech Transfer Process & Operations
• Clinical and Commercial Manufacturing
• Operations Support
• Material Flow for Chemicals and Raw Materials

Session 3:

• Raw Material Challenges
• COVID and Post COVID Reality
• Emerging New Technologies

Instructors

David Lai
Lead Supply Chain Specialist, Thermo Fisher Scientific

David currently leads the Supply Chain Projects team at Thermo Fisher’s St. Louis Biologics facility, based in St. Louis, MO.  With more than 18 years in the biotechnology industry, David has extensive experience with roles in Manufacturing operations and Supply Chain, partnering local and global teams from Quality and Engineering.  David has worked in multi-product and high through-put organizations such as Amgen (Rhode Island and Fremont, CA), Boehringer-Ingelheim, Shire, Takeda and now Thermo Fisher Scientific leading cross-functional teams on problem-solving and create success through continuous improvement efforts.  He also supports local continuing education Biotechnology programs in Massachusetts with Middlesex Community College and Northeastern University since 2016, and graduated from Providence College with a Bachelor’s degree focused in Biology.

Nazma M. Rosado, MAOL, PMP, CMQ/OE
Principal Consultant, Avion Consulting

Nazma has over 25 years of experience in the leadership, team and organizational development spaces. She served as the Global Head of Organizational Development at several large Pharma companies prior to her transition to consulting. She works with senior leaders to help change behaviors that shape the company’s culture and increase employee engagement, inclusion, and belonging. Nazma has a passion for people and a strong desire to make the workplace more diverse, engaging, and productive by choice. She is an experienced executive coach and has helped senior leaders develop their staff, teams, and selves.

Nazma is a versatile and results-driven consultant with demonstrated experience in executive coaching, team development, business process optimization and change management practices. She is highly skilled at training strategy design/delivery, change management needs identification, and creating cultures that value diversity, equity, and inclusion. She is an analytical and strategic thinker who develops scalable, repeatable, and sustainable strategies and results; strategically utilizes instructor-led, eLearning and web-based curricula to deliver maximum results and uses analytics to determine ROI.

Nazma has a B.A. in Neuroscience and a B.A. in Psychology from Colgate University and a M.A. in Organizational Leadership from Gonzaga University. Nazma has earned many professional certifications including Project Management Professional (PMP), Six Sigma Green Belt (6σ), and Certifications in Change Management from APMG and Prosci.