Helene Shea
VP CMC & Technical Operations | Clinical-to-Commercial Manufacturing & Supply Strategy
- Role
- Vice President Cmc at Promontory Therapeutics
- Location
- Rutland, MA, US
- LinkedIn followers
- 500 followers
About Helene Shea
VP level CMC and Technical Operations executive with deep experience leading global development, manufacturing and supply chain strategies across drug substance, drug product, and combination products. Proven track record of building and leading high-performing teams while providing strategic oversight to external manufacturing partners (CDMOs) to advance programs from early development through commercialization. Extensive experience partnering with CMC, Regulatory, and Quality teams to author and support global CMC modules for FDA, EMA, and Health Canada submissions. Recognized for implementing phase-appropriate CMC and manufacturing strategies that balance speed, risk, and long-term scalability.Comfortable operating independently or in highly cross-functional environments, with a leadership style grounded in clear, effective oral and written communication. Fluent in English and French.
Experience
Vice President Cmc
Jul 2022 — Present · Manhattan, NY, US
Education
Dartmouth College
PhD, Organic Chemistry
1990 — 1995
College of the Holy Cross
BA, Chemistry
1986 — 1990
Skills
- Chromatography
- Gas Chromatography
- Hplc
- Standard Operating Procedure (Sop)
- Biotechnology
- Organometallic Chemistry
- Pharmaceutical Industry
- Sop
- Fda
- Organic Chemistry
- Chemistry
- Drug Discovery
- Organic Synthesis
- Drug Development
- Biopharmaceuticals
- Spectroscopy
- Glp
- Lc-Ms
- Technology Transfer
- Uv/Vis
- High-Performance Liquid Chromatography (Hplc)
- Gmp
- Nmr
- Validation
- Mass Spectrometry
- Medicinal Chemistry
- Good Laboratory Practice (Glp)
- Analytical Chemistry
- R&D
- Ir
- Purification
- Process Simulation
- Uv/Vis Spectroscopy
- Catalysis
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