job summary: **IMMEDIATE NEED
for a Director, Product Development
. This person MUST have good proven experience with filing ANDAs for various dosage forms.**
location: Allentown, Pennsylvania
job type: Permanent
salary: $170,000 - 190,000 per year
work hours: 9 to 5
- Drive the Company's progress on new product development projects, including product identification and assessment, Quality-by-Design, pre-formulation, formulation, scale-up, stability and any other activity related to development of new product initiatives
- Develop processes for scale-up and commercial batches.
- Prepare reports for Product Development documentation, under current quality guidances issued by FDA, including Quality-by-Design theories, used to support regulatory filings for FDA submissions (i.e. ANDA, 505(b)(2) NDA, etc).
- Troubleshoot issued encountered in production affected by product formulations and processes.
- Investigate scientific characteristics of new solid-dose or liquid pharmaceutical products with the intention of developing stable product formulations and development protocols, according to regulations and guidance issued by the Food and Drug Administration.
- Bachelor's Degree in Science
- Minimum of ten years' experience in a product formulation and product development function of a prescription pharmaceutical manufacturer, preferably in the generic industry
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.