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James Schwing is listed as Pharmaceutical Professional based in Mount Laurel, New Jersey, United States. AeroLeads shows a work email signal at fhfa.gov and a matched LinkedIn profile for James Schwing.
James Schwing previously worked as Senior RIM Consultant, Regulatory Information Management Services at Lancesoft, Inc. (Under Contract To) Bristol Myers Squibb and Consultant, Biotherapeutics Development Material Sciences at Pharma Resource Group, Inc. (Under Contract To) Janssen Pharmaceutical Research And Development. James Schwing holds Candidate For Doctor Of Philosophy, Pharmaceutics from University Of The Sciences In Philadelphia.
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Pharmaceutical professional with experience in all phases of dosage form development, from preformulation, to scale up and validation, to filing and assessment of regulatory submissions. Skilled in data organization, analysis, presentation, and review.Specialties:• Clear and precise technical writing, and preparation of informational material appropriate for target audience.• Critical review of regulatory documentation, with identification of gaps and deficiencies.• Effective presentation skills, with active solicitation of questions to provide immediate insight and solutions.• Extensive experience with pharmaceutical formulation, and physical and chemical characterization:o Efficient design of solid, liquid, and semi-solid formulations, especially modified-release dosage formso Pharmaceutical analysis, including dissolution testing, chromatography, thermal analysis, rheological testing, texture analysis, and transdermal diffusion testingo Pharmacokinetic and pharmacodynamic analyses, and modeling of gastrointestinal drug absorption
Listed skills include Formulation, Fda, Technical Writing, Technology Transfer, and 24 others.
A career timeline built from the work history available for this profile.
Lawrenceville, New Jersey, United States
Managed regulatory information for commercial and investigational products in the system for submissions, approvals and associated product data. Ensured that regulated data were complete, accurate, and up to date.
Malvern, Pennsylvania, United States
Performed detailed Bill of Materials Assessments, ensuring that quality and test methods for starting materials, process chemicals and polymeric articles were appropriate for the phase of biotechnological manufacturing. Created and revised material specifications, risk assessments, stability reports, and technical reference documents.
Silver Spring, Maryland
Center for Drug Evaluation and Research, Office of Pharmaceutical Quality, Office of Lifecycle Products, Division of Modified Release ProductsReviewed chemistry, formulation, controls, technical aspects of labeling, and environmental impact information submitted in Abbreviated New Drug Applications (ANDAs). Evaluated testing and control of starting.
Philadelphia, Pennsylvania, United States
In support of dissertation research topic “Production of Infliximab-Loaded PLGA Microspheres by Spray Drying”, carried out experiments, compiled and presented results. Mentored peers and undergraduate students.
Wilmington, Delaware, United States
Responsibilities included gaining a deeper understanding of the function of polymeric products, development of new functional excipients, customer support and training, and development of improved sales tools.
Fort Washington, Pennsylvania, United States
Led characterization of raw materials, intermediates and finished product for a novel dosage form technology. Developed quantitation and characterization methods for polymeric materials in processed intermediates.
Fort Washington, Pennsylvania, United States
Devised physical and chemical characterization methods for novel dosage form technologies.
Fort Washington, Pennsylvania, United States
Carried out product development and pre-commercialization experiments.
King Of Prussia, Pennsylvania, United States
Conducted preclinical development of dosage forms for new chemical entities. Planned and carried out preformulation experiments and performed lab-scale and pilot-scale processing.
Fort Washington, Pennsylvania, United States
Characterized new materials and carried out preformulation experiments, developed prototypes of new drug delivery dosage forms, and conducted forensic investigations on marketed product samples.
Fort Washington, Pennsylvania, United States
Carried out preformulation, product development and pre-commercialization experiments, applying physical pharmacy and analytical chemistry.
Fort Washington, Pennsylvania, United States
Developed in vitro tests of cholesterol-lowering food product performance, performed chemical analyses of nutritional products, and supported formulation development by novel physical characterization methods. Performed forensic examinations of raw materials and finished products.
Fort Washington, Pennsylvania, United States
Developed topical gel formulations of non-steroidal anti-inflammatory drugs, devised in vitro transdermal diffusion tests and analytical methods for topical semi-solid formulations.
Fort Washington, Pennsylvania, United States
Analyzed and reported on human bioavailability studies; assembled biopharmaceutics sections of FDA submissions. Developed modified-release dosage forms; carried out physical and chemical characterization. Led topical NSAID team and performed in vitro transdermal diffusion testing of topical NSAID gels.
Fort Washington, Pennsylvania, United States
Developed modified-release dosage forms, performed analytical testing. Scheduled, analyzed and reported on human bioavailability studies, and incorporated results into New Drug Applications.
Fort Washington, Pennsylvania, United States
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James Schwing is listed as Pharmaceutical Professional.
AeroLeads has found 2 work email signals at @fhfa.gov for James Schwing.
James Schwing is based in Mount Laurel, New Jersey, United States.
James Schwing has worked for Lancesoft, Inc. (Under Contract To) Bristol Myers Squibb, Pharma Resource Group, Inc. (Under Contract To) Janssen Pharmaceutical Research And Development, Fda, University Of The Sciences In Philadelphia, and Ashland.
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James Schwing holds Candidate For Doctor Of Philosophy, Pharmaceutics from University Of The Sciences In Philadelphia.
James Schwing is listed with skills including Formulation, Fda, Technical Writing, Technology Transfer, Drug Delivery, Chromatography, Laboratory, and Thermal Analysis.
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