Daniel Hill Email & Phone Number

Richmond, Virginia, US

Responsible and accountable to ensure active pharmaceutical ingredient (API) process development from early R&D all the way to commercial manufacturing is executed with an emphasis on quality, robust, streamlined and cost-effective processes. Work with strategic partners as a technical lead across multiple project teams and develop phase-appropriate API.

Gaithersburg, Maryland, US

• As Director – Product Development Technical Lead, I develop strategies to propel program momentum, address issues, and avoid risks. Championing technical aspects of phase one drug development programs, ensuring on-time.
• Pioneered strategy and technical facets of investigational nasally administered combination product to Phase one completion.
• Crafted drug substance and drug product regulatory submissions.
• Headed drug substance and drug product manufacturing campaign including fill-finish operations.

Gaithersburg, Maryland, US

• In this role, I managed autoinjector programs within Device Business Unit as lead scientific expert. Executing formulation development, drug product manufacturing, fill-finish for drug containing constituent.
• Developed formulations and completed registration batches for three parental drug products, including fill finish.
• Headed early phase API manufacturing initiatives for preclinical evaluations and Phase one FIH studies while championing API process discovery and development.
• Emerged as lead technical process chemistry expert during API quality audits.
• Formulated IND submission documentation for FDA-approved drug substances and products.

Gaithersburg, Maryland, US

• As Principal Scientist, I headed organic synthesis, drug discovery, and drug development. Developing API chemical processes, early phase solid forms, and product development for external contract research organizations.
• Implemented make/test/design cycles and curated SAR data for early phase drug discovery projects.
• Finalized five pre-clinical lead candidates after multiple make/test design cycles.
• Streamlined 12-step synthesis process to 8-step telescoped route for novel Topoisomerase inhibitor and magnified synthesis to kilogram scale.
• Produced 10 kg of lead candidate for preclinical progression under cGMP.
• Found groundbreaking formulation incorporating Vitamin K, excipient that meets GRAS standards, for program consideration.

Maple Grove, MN, US

• At Upsher-Smith Laboratories, I promoted chemical reactivity and structure-based expertise across organizational departments as well as directed external CRO efforts in chemical process evolution, impurity probes, and.
• Achieved validation of cGMP manufacturing process for anabolic steroid in 18 months, encompassing three registration batches.
• Implemented manufacturing campaign to deliver 100kgs of API for Phase two study.
• Increased yield by 50% and reduced impurities from 0.7% to undetectable levels by increasing synthesis process from gram to 20kg.
• Formulated manufacturing protocol for pro-drugs for preclinical toxicology at 8kg scale.
• Partnered with internal customers Proximagen and Pairnomix on early-stage discovery initiatives.

Postdoctoral Research Fellow, Organic Chemistry - Carbohydrate Synthesis, Nitrene And Aziridine Methodology Development

Doctor Of Philosphy, Organic Chemistry - Polyamine Macrocycles

Bachelor Of Arts - Ba, Chemistry And Biology