Mani S.
Senior Vice President, Technical Operations at Fulcrum Therapeutics
- Role
- Senior Vice President, Technical Operations at Fulcrum Therapeutics
- Location
- Wilmington, DE, US
- LinkedIn followers
- 500 followers
About Mani S.
Executive with broad experience and expertise in global manufacturing and supply of biopharmaceuticals. Demonstrated track record in building high performance organizations focused on creating sustainable value for stake holders while delivering the highest standards of safety, quality, compliance, and supply assurance.Expertise in broad spectrum of pharmaceutical technologies, including, fine-chemicals, manufacturing, packaging, validation, formulation, and process development for dosage forms including, parenterals, tablets, capsules, oral liquids, topicals, suppositories, conventional & novel drug delivery systems.
Experience
Senior Vice President, Technical Operations
Jul 2021 — Present · Boston, MA, US
Accountable for Late Stage Development (i.e, defining and executing, process / formulation development - API & Drug Product), external manufacturing operations and clinical / commercial supply strategies for the company’s growing portfolio of late stage rare disease assets.
Education
Institute Of Chemical Technology
B.Sc. (Tech.), Pharmaceuticals & Fine Chemicals Technology
Temple University
MS, Pharmaceutical Sciences
University of Pennsylvania
MSE, Management of Technology
Temple University
Ph.D., Pharmaceutical Sciences
University of Pennsylvania
Fellow School of Engineering & Applied Sciences, Engineering
Loyola College
B.Sc., Chemistry
Stakeholder Impact Foundation
SLGI Fellowship, Board Governance
Skills
- Gmp
- Quality System
- Process Simulation
- Supply Chain
- Regulatory Requirements
- Pharmaceutics
- Regulatory Affairs
- Lifesciences
- Cmc
- Pharmaceutical Industry
- Fda
- Strategy
- Formulation
- Validation
- Quality by Design
- Biopharmaceuticals
- Drug Delivery
- Six Sigma
- Life Sciences
- Quality Auditing
- Aseptic Processing
- Biotechnology
- Process Engineering
- Technology Transfer
- R&D
- Operational Excellence
- Regulatory Submissions
- Manufacturing
- Technical Services
- Cross-Functional Team Leadership
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