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Scientist, Formulation Development

IntegratedResourcesINC

East Windsor, NJ, United States permanent

Posted: August 3, 2017

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Quick Summary

A scientist with experience in formulating generic drug dosage forms (orals/liquids) is required for this role. The ideal candidate should have a thorough understanding of the ANDA filing process and be able to perform extensive literature search on assigned projects.

Required Skills

Formulation Development ANDA Filing Literature Research Process Development Pharmaceutics Pharmacokinetics Scale Up SOP Updates Equipment Requirements Training Needs Analysis

Job Description

Scientist, Formulation Development

JOB SUMMARY

REPORTING RELATIONSHIPS

This role reports to the V.P. RD Orals

This role has no direct reports

DUTIES & ESSENTIAL JOB FUNCTIONS

· Formulator 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 development

· Experience working with projects from bench-top stage to large scale manufacture of submission batches

· Should have a sound knowledge of pharmaceutics, pharmacokinetics and process scale-up

OTHER FUNCTIONS AND RESPONSIBILITIES

Suggest 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.

QUALIFICATIONS

Formulation development and process development scientist with 3+ years of experience in the generic drug industry with ANDA filing experience.

REQUIRED

MS or PhD in Pharmaceutics or related field

PREFERRED

Experience in working with DEA controlled drug substances and relevant regulations.

Experience in developing controlled-release product using Fluid Bed Processor (Wurster coating) technology.

Quick Checklist

Candidates 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 skills

Candidates would definitely need Formulation Development and Process Development background. Both are a must.

All your information will be kept confidential according to EEO guidelines.

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