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Innovative Ph.D. Chemical Engineer and Pharmaceutical R&D Executive with 25+ years of expertise in sterile and non-sterile formulations, CMC strategy, and regulatory success. Proven leader in driving product approvals (18 NDA/ANDA) with $6B in revenue while mentoring high-performing teams.Career highlights include:• 3 NDA approvals (e.g., Jublia, Kerydin) and 15 ANDA approvals for generic topical, transdermal, and injectable products.• 25+ patents in formulations, delivery systems, and minimally invasive diagnostics.• Pioneered FDA biowaiver pathway for generic topical products.SpecialtiesProduct Development Expertise: Complex formulations (topical, transdermal, sterile injectable combination products), extended release, and controlled drug delivery.Leadership Skills: Team building, R&D strategy, and cross-functional collaboration.Regulatory Success: Global ANDA and NDA.
Tolmar
View- Website:
- tolmar.com
- Employees:
- 941
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Interim Vice President And Senior Director, Manufacturing Science And TechnologyTolmarFort Collins, Co, Us
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Interim Vice President/Senior Director, Manufacturing Science And TechnologyTolmar Feb 2020 - PresentFort Collins, Co, UsHead of newly formed Manufacturing Science and Technology department, leading 17 engineers and scientists. This department was created to oversee lifecycle management of Tolmar's existing portfolio of specialty injectable and dermatology products, and to manage the transition of new products from R&D to commercialization.
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Vice President, Product DevelopmentTolmar 2017 - Feb 2020Fort Collins, Co, UsHead of product development for dermatology and proprietary complex injectable programs. Lead a team of 12 scientists responsible for formulation and process development of generic and proprietary products. Hired to remediate deficiencies in CMC processes and accelerate product development and approvals. Enhanced QBD know-how and strengthened project management discipline. Established new technology capabilities at commercial scale.
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Senior Director, Topical Product R&DMylan 2007 - 2017Canonsburg, Pennsylvania, UsProgressive promotions from manager to multidisciplinary platform leader responsible for CMC activities to advance Mylan's portfolio of topical and transdermal products. Managed a team of 16 scientists. Persuaded Mylan management to invest in high-value generic topical product development which ultimately generated >$500m in annual revenue. Created the scientific argument that led to a change in the FDA requirements for topical drug approval. -
Manager, Formulation & Process DevelopmentDow Pharmaceutical Sciences, Inc. 2004 - 2007Supervised teams up to 5 chemists developing formulations for topical, buccal, and ophthalmic drugs. Invented and patented novel formulation to treat fungal infections. Recognized by clients for high productivity of team.
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PrincipalFieldson Consulting 2002 - 2004Provided competitive intellectual property analyses to pharmaceutical clients including ALZA.
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Director Of Biochip EngineeringLumicyte, Inc. 2000 - 2002One of the company's first employees. Responsible for multiple projects including the fabrication of the company's biochip for protein capture and assay. Supervised a team of scientists and managed external contract fabrication operations.
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Research ScientistAlza Corporation 1994 - 2000Seattle, Washington, UsResponsible for product development and applied research on controlled transdermal drug delivery systems. Foundation role that established CMC and GxP capabilities.
Gregory Fieldson, Ph.D. Skills
Gregory Fieldson, Ph.D. Education Details
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The Johns Hopkins UniversityChemical Engineering -
Rensselaer Polytechnic InstituteChemical Engineering
Frequently Asked Questions about Gregory Fieldson, Ph.D.
What company does Gregory Fieldson, Ph.D. work for?
Gregory Fieldson, Ph.D. works for Tolmar
What is Gregory Fieldson, Ph.D.'s role at the current company?
Gregory Fieldson, Ph.D.'s current role is Interim Vice President and Senior Director, Manufacturing Science and Technology.
What is Gregory Fieldson, Ph.D.'s email address?
Gregory Fieldson, Ph.D.'s email address is gf****@****mar.com
What is Gregory Fieldson, Ph.D.'s direct phone number?
Gregory Fieldson, Ph.D.'s direct phone number is +197021*****
What schools did Gregory Fieldson, Ph.D. attend?
Gregory Fieldson, Ph.D. attended The Johns Hopkins University, Rensselaer Polytechnic Institute.
What skills is Gregory Fieldson, Ph.D. known for?
Gregory Fieldson, Ph.D. has skills like Formulation, Drug Delivery, R&d, Product Development, Gmp, Pharmaceutical Industry, Technology Transfer, Biotechnology, Chemistry, Validation, Pharmaceutics, Analytical Chemistry.
Who are Gregory Fieldson, Ph.D.'s colleagues?
Gregory Fieldson, Ph.D.'s colleagues are Rachel Von Seggern, Derek Johnson, Amanda Sternhagen, Tony R., John Harding, Jeff Visconti, Jean Graves.
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