Mark Waskiewicz
Executive Level Vaccines/Biologics CMC Strategy Expert | Integrating Technical Development and Commercialization Strategy with Clinical, Commercial, and Regulatory Requirements
- Role
- Development and Commercialization Leader at Merck
- Location
- Norristown, PA, US
- LinkedIn followers
- 500 followers
About Mark Waskiewicz
Seasoned head of CMC strategy development, regulatory submissions oversight, and project management with 30 years of experience on complex biological products and vaccines. Proven track record in leading both regulatory and CMC operations teams, developing and executing successful CMC strategies for global submissions in all development phases (IND, CTA, BLA, MAA, post-approval). Expertise in navigating complex regulatory landscapes and ensuring compliance with global regulations. Proven ability to establish cross-functional teams and procedures for CMC development, cultivating strong relationships with internal and external stakeholders, including regulatory agency staff. Adept at analyzing technical information, identifying gaps, and implementing improvements that support global submissions, enhance efficiency, and achieve organizational goals.
Experience
Development and Commercialization Leader
Jan 2025 — Present · West Point, PA, US
Responsible for end-to-end technical product leadership of CMC teams and delivery of a fully integrated development and commercialization strategy and timeline to ensure successful launch and long-term supply of biological/vaccine products. Identify, manage, and communicate risks on the programs. Ensure robust process and analytics, integrated control strategy, compliant regulatory submissions, and robust supply chain.
Education
Rutgers University
MS, Biochemical Toxicology
University of the Sciences in Philadelphia
BS, Pharmacology & Toxicology
Rutgers Robert Wood Johnson Medical School
MS, Biochemical Toxicology
Skills
- Analytical Chemistry
- Strategy
- Therapeutic Areas
- Biologics
- Change Control
- Biotechnology
- Glp
- Cmc
- Regulatory Affairs
- Drug Development
- Biopharmaceuticals
- Cmc Regulatory Affairs
- Toxicology
- Regulatory Submissions
- Fda
- Quality System
- Quality Systems
- Vaccines
- Validation
- U.s. Food and Drug Administration (Fda)
- Regulatory Requirements
- Ind
- Regulatory Strategy
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