John Simons
About
John Simons is from Cary, North Carolina, United States. John works in the following industries: "Pharmaceuticals". John is currently VP of Product Development at Vast Therapeutics, located in Durham, North Carolina. In John's previous role as a Director Of Product Development at Catalent Pharma Solutions, John worked in Raleigh-Durham, North Carolina Area until Mar 2019. Prior to joining Catalent Pharma Solutions, John was a Director at Teva Pharmaceuticals and held the position of Director at Miami/Fort Lauderdale Area. Prior to that, John was a Technical Project Leader at 3M Drug Delivery Systems from Jul 2008 to Aug 2013. John started working as MTS Project Leader at 3M Drug Delivery Systems in Mar 2005. From Mar 2002 to Mar 2005, John was Project Group Leader at 3M Drug Delivery Systems. Prior to that, John was a Analytical Inhalation Group Leader at 3M Drug Delivery Systems from May 2000 to Mar 2002.
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John Simons's current jobs
John Simons's past jobs
Oversaw the CMC development of all inhalation and nasal product programs from phase I to phase IV including clinical manufacturing, stability testing and trending, drug product characterization studies, method development, specifications development, method validations, method transfers, out of specification investigations, and providing required documents to support regulatory filings. Worked with business development team to quote and bring in new business: $10M. Supported two partner submissions: one MDI ANDA and one nasal spray NDA.
Managed the analytical laboratory supporting the development of two dry powder inhaler products (three strengths per product). Drove the analytical development activities and strategic decisions to support product development: Stability testing and trending, drug product development studies, method development, specifications development, method validations, method transfers, out of specification investigations, and writing of CMC sections. Filed and gained first round approval for AirDuoTM RespiClick and ArmonAirTM RespiClick products.
Successfully lead a $4M project to evaluate the feasibility of a new Taper DPI product with a customer’s new drug. Produced and cleared clinical supplies on time for the customer’s clinical program. Successfully lead project team of 15 people to produce and clear clinical supplies on time for a new Fluticasone/Salmeterol DPI formulation. Oversaw the development of key processes including web fabrication, powder blending, powder coating and slitting of webs.
Led a diverse project team (engineers, formulators, and analysts) in development of a new-to-market transdermal combination product (MTS) for delivering vaccines and proteins. Lead partner team to evaluate MTS with partner’s vaccine ($7 M in sold R&D) culminating in the initiation of a Phase I clinical study. Managed key interactions with the partner. Responsible for managing overall program assignments and personnel performance (12-16 people, technicians up to experienced PhDs). Oversaw the development of phase I clinical manufacturing processes (injection molding of microreplicated arrays) and installed an aseptic, phase I pilot scale manufacturing line. Set strategies for IP evaluations and prioritization.
Managed a group of synthetic, formulation, and analytical scientists that evaluated and developed metered-dose inhaler formulations for customer-owned drug substances with 3M-developed excipients (oligolactic acids or OLAs). Recruited and hired scientists to grow group from 10 to 30 within one year. Responsible for managing group assignments and personnel performance (15-20 people, technicians up to T5). Co-leader of a joint 3M/partner technical team which evaluated eight different individual drug substances, as well as several combinations of the drug substances. Team received the Golden Step Award for efforts (project achieved $10 M in R&D revenue).
Managed analytical laboratory responsible for supporting all inhalation product development projects. Supported new partner projects by recruiting and hiring scientists to increase staff from 15 to 30. Worked closely with quality assurance, regulatory, and manufacturing sites to develop appropriate product development and commercialization strategies.