Name:
William Joseph Lambert
Country:
USA
City:
Incline Village
State/Province:
NV
ACS Member:
Member
Local Section:
L629,Sierra Nevada
International Chapter:
Technical Division Membership:
Technical Division Membership Emeritus:
Subdivision Member:
ACS Activities:
Company/Institution Name:
Module 3 Pharmaceutical Consulting
Career Stage:
Retired
Research and Special Interests:
• Bill’s 30+ years of experience includes:
• Executive team membership reporting to CEO for two public companies including one that was venture capital funded and had a successful product launch and IPO
• Writing and review of Module 3 CMC section of eCTD regulatory filings (IND, IMPD, NDA)
• Experience working with corporate board of directors
• Significant experience in due diligence and consulting business development groups from both the acquirer and acquiree standpoint
• Member of multiple development leadership teams for both big pharmaceutical and big biotech companies
• Optimization and lead selection of drug candidates, both large and small molecule
• Experience managing CMOs, CDOs, and CROs
• Contributed to the development and global regulatory registration efforts of several marketed drugs including Corvert (anti-arrhythmic), Trovan (antibiotic), Halaven (anti-cancer), Exparel (post-surgical pain), Fasenra (benralizumab, asthma), and Omidria (ophthalmic surgery)
• Experience in discovery support, development, sourcing, and commercial operations.
• Managed budgets of up to $20MM
• Knowledgeable in intellectual property including the management of a large patent portfolio
• Member of multiple scientific advisory boards
• Subject matter expert in sterile product formulation and analytical development, aseptic processing, tech transfer, drug delivery, combination product devices, cGMPs, and life cycle management
Area of Expertise:
pharmaceutical development, formulation, analytical, CMC, sterile products
Years of Expertise:
21-25