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Skills
Abbreviated New Drug Applicationunmatched
Dosage Formsunmatched
Industrial Developmentunmatched
Operations Processesunmatched
Oral Administration Drugsunmatched
Pharmaceuticsunmatched
Pharmacokineticsunmatched
Presentation/Verbal Skillsunmatched
Process Developmentunmatched
Regulationsunmatched
Standard Operating Procedures (SOP)unmatched
Team Playerunmatched
United States Drug Enforcement Agency (DEA)unmatched
Writing Skillsunmatched
Description
Scientist, Formulation DevelopmentScientist, Formulation DevelopmentJob SummaryThis role reports to the V.P. RD OralsThis role has no direct reportsDuties & Essential Job FunctionsFormulator with previous industrial experience developing and filing generic drug dosage forms (orals/liquids)Ability to perform extensive Literature Search on assigned Projects.Thorough understanding of the ANDA (and preferably NDA) filing process in line with QbD elements in generic product developmentExperience working with projects from bench-top stage to large scale manufacture of submission batchesShould have a sound knowledge of pharmaceutics, pharmacokinetics and process scale-upOther Functions and ResponsibilitiesSuggest improvements and efficiencies in the department. Assist in revising and maintaining SOPs, operating procedures and other documents.Suggest new equipment and or training for personnel.QualificationsFormulation development and process development scientist with 3+ years of experience in the generic drug industry with ANDA filing experience.RequiredMS or PhD in Pharmaceutics or related fieldPreferredExperience in working with DEA controlled drug substances and relevant regulations.Experience in developing controlled-release product using Fluid Bed Processor (Wurster coating) technology.Quick ChecklistCandidates will need to have all of the requirements on the job description especially this part:Formulation development and process development scientist with 3 or more years of experience in the generic drug industry with ANDA filing experience.Must have ability to work in a team with excellent spoken and written communication skillsCandidates would definitely need Formulation Development and Process Development background. Both are a must.Additional InformationAll your information will be kept confidential according to EEO guidelines.