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Accomplished, quality-oriented product development scientist with a history of leadership and achievement in the pharmaceutical industry. I am passionate about improving operational and process efficiencies within cross-functional teams and laboratories to ensure quality drug products are developed which meet both regulatory standards and business objectives. I have extensive experience with project/laboratory leadership in GMP-compliant laboratories. My areas of expertise include the following: -Analytical Laboratory Management -Analytical Method Development and Validation -Product Development Managment -Device/Drug Combination Products (MDIs, DPIs and Transdermal Patches) -Deviaiton/OOS Management -Clinical Manufacturing -Six Sigma -DOE -Quality Common Technical Document Contact Information: jksimons31@gmail.com
Vast Therapeutics
View- Website:
- vasttherapeutics.com
- Employees:
- 12
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Vp Of Product DevelopmentVast Therapeutics Jul 2019 - PresentDurham, North Carolina
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Director Of Product DevelopmentCatalent Pharma Solutions Jul 2017 - Mar 2019Raleigh-Durham, North Carolina AreaOversaw 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. -
DirectorTeva Pharmaceuticals Aug 2013 - Jul 2017Miami/Fort Lauderdale AreaManaged 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. -
Technical Project Leader3M Drug Delivery Systems Jul 2008 - Aug 2013Successfully 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. -
Mts Project Leader3M Drug Delivery Systems Mar 2005 - Jun 2008Led 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.
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Project Group Leader3M Drug Delivery Systems Mar 2002 - Mar 2005Managed 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).
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Analytical Inhalation Group Leader3M Drug Delivery Systems May 2000 - Mar 2002Managed 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.
John Simons Skills
John Simons Education Details
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Chemistry -
Chemistry
Frequently Asked Questions about John Simons
What company does John Simons work for?
John Simons works for Vast Therapeutics
What is John Simons's role at the current company?
John Simons's current role is VP of Product Development at Vast Therapeutics.
What is John Simons's email address?
John Simons's email address is jk****@****hoo.com
What is John Simons's direct phone number?
John Simons's direct phone number is +165173*****
What schools did John Simons attend?
John Simons attended University Of Wisconsin-Madison, Brigham Young University.
What skills is John Simons known for?
John Simons has skills like Laboratory, Project Management, Written Communication, Fda, Supervision.
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