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Req197387
Location
Piscataway, NJ, United States
Job Type
Category

Description

We are looking for a Director of Formulation in R&D, for a Central NJ based fully integrated pharmaceutical company, with OTC, Generic, and Brand RX business.

  • Supervise and reports of overall product development activities to Sr. VP of R&D.
  • Issues of meeting time line, enhancement of personal step up activities.
  • Analysis and resolutions for projects progression blocks of specifically of ANDA and generally other projects in lines of R&D layer out.

Duties & Requirements:

  • Pre-formulation as well as formulation development experience.
  • Screening of polymers and other excipients selections to enhance low solubility APIs.
  • Development of Generic products for ANDA filings
  • Group Leader to have combined Pharmaceutical R&D, Solid Oral dosage inclusive of Hard shell capsules.
  • Modified release and immediate release solid dosage forms.
  • Should have knowledge to carry out projects of alternative dosage delivery  505b2.
  • Design of experiments for robust formulation development.
  • Manufacturing of feasibility and submission batches for stability & clinical studies.
  • Performance of scale up batches .
  • Documentation development report and CMC documents in support ANDA filings
  • Full knowledge and implementation of quality by design(QBD) and GMP regulations in execution of MBR for new products.
  • Involve in new product transfer to third parties facilities.
  • Perform ,review and analyze the data collected for formulation and process development , establish critical process and attributes for future products development.
  • Cross functional activities amongst related company's department needed specially QA/QC/Regulatory.
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