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.