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 manufacturing processes suitable for tech transfer from R&D to commercial manufacturing facilities. Drive and support innovation across the development and commercial portfolio to ensure we have a reliable US supply chain of essential medicines.

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 project milestone realization, I coordinate with senior leadership on product development plans, milestones, budgets, and forecasting. I also secure program deliverables through cross-functional communication as well as oversee drug product manufacturing, device design, engineering, regulatory, and outsourcing activities. Additionally, I fulfill program requirements internally and externally.A few highlights of my accomplishments include:● 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, analytical method validation, transfers, and API process development and manufacturing for external contract research organizations (CROs), I supervised external CRO teams to guarantee timely achievement of project milestones and deliverables. I also assisted external CROs in developing and validating analytical methods for device business as well as drafted proposals targeting external funding opportunities.A few highlights of my accomplishments include:● 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 (CROs), I managed external CRO teams to ensure timely completion of milestones and contributed to discovery and development of API processes with emphasis on synthesis route selection, optimization, and validation. Additionally, I identified and characterized impurities for toxicological evaluation as well as team of technical process chemists during API quality audits.A few highlights of my accomplishments include:● 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.● Nominated lead series for preclinical testing in animal models based on SAR insights across diverse programs.● Formulated syntheses for stable isotope labels to bolster bioanalytical method development.

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 structural determination, while managing adaptive team. Developing API processes for early- to late-phase programs and commercial entities, I validated purity, particle size, crystalline benchmarks by integrating quality, chemistry, analytical sciences, and clinical teams along with delivering drug substances on time for toxicological scrutiny and human trials. I also investigated impurity structures for commercial and advanced development entities and refined pipeline program methodologies by strengthening chemical knowledge and fostering swift problem resolution. Additionally, I pinpointed core issues behind discrepancies among number of excipients and advocated formulation strategies cognizant of potential excipient-drug synergies. I also procured essential chemicals from diverse suppliers, demonstrating proficiency with API requirements.A few highlights of my accomplishments include:● 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.● Served as paramount technical chemistry authority during API quality reviews.● Crafted meticulous documents for NDA and ANDA submissions.

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