- Oversee production operations to ensure that the manufacturing process runs smoothly, efficiently, and on budget.
- Lead investigations across the manufacturing and distribution network.
- Assess future clinical and commercial demand of products and planning manufacturing schedules to ensure uninterrupted supply,
- Selection and negotiation of contracts with suppliers, distributors and CMOs.
- An advanced degree in Chemistry/ Chemical Engineering with a minimum of 15 years of broad-level leadership experience in manufacturing and supply chain management of clinical-stage and commercial pharmaceuticals.
- Experience in manufacturing of peptides at large scale would be preferable.
- Experience in negotiating contracts and managing an external manufacturing network of vendors for drug substance, drug product and devices.
- Demonstrated success in regulatory inspection of manufacturing sites.
- Knowledge of US and international supply chain architecture including vendor qualification and selection.
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Vice President, Manufacturing
2 weeks ago
FogPharma Cambridge, United StatesJob Description · Job DescriptionWhy Join Us? · FogPharma is pioneering the discovery, development, and commercialization of HeliconTM peptides, an exciting new drug modality that uniquely combines the cell-permeability of traditional small molecule drugs with the specificity, br ...
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Vice President, Manufacturing
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FogPharma Cambridge, United StatesWhy Join Us?FogPharma is a biopharmaceutical company pioneering the discovery and development of HeliconTM therapeutics, which are peptides capable of efficient cell entry and modulation of both protein-protein and protein-DNA interactions. Through Helicon therapeutics, FogPharma ...
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FogPharma Cambridge, United StatesFogPharma is pioneering the discovery, development, and commercialization of Helicon TM · peptides, an exciting new drug modality that uniquely combines the cell-permeability of traditional small molecule drugs with the specificity, broad target accessibility and discovery speed ...
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Vice President, Manufacturing - Cambridge, United States - FogPharma
Description
Job Description
Job DescriptionWhy Join Us?
FogPharma is a biopharmaceutical company pioneering the discovery and development of HeliconTM therapeutics, which are peptides capable of efficient cell entry and modulation of both protein-protein and protein-DNA interactions. Through Helicon therapeutics, FogPharma is poised to revolutionize the medical possibilities for patients by precisely drugging intracellular targets long understood to be significant drivers of disease but never before drugged due to the limitations of existing drug modalities to act within the cell.
FOG-001, the company's first-in-class TCF-blocking β-catenin inhibitor, is being evaluated in a Phase 1/2 study for patients with advanced solid tumors, including colorectal cancer. FogPharma is fully leveraging the unprecedented potential Helicons present by deploying proprietary, custom-built machine learning and computational methods as part of its discovery and development process. FogPharma has raised more than $500 million to date from leading life sciences investors. FogPharma is headquartered in Cambridge, Mass.
What's the opportunity?
The VP of Manufacturing will be responsible for the overall management of the manufacturing network and planning of the manufacturing strategy to enable cost-effective supply of clinical and future commercial products world-wide. This role reports to the Chief Technical Officer and works closely with Pharmaceutical Development, Clinical, Quality and Finance teams. This is a highly influential role with a significant level of impact across the company.
Responsibilities
What you'll need to be successful:
As an equal opportunity employer, Fog values diversity and welcomes applicants of all backgrounds and experiences. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.
