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Scientific Product Development Manager
1 month ago
At Aragen Bioscience, we are seeking an experienced Senior Scientific Manager to lead our product development efforts in oral solid dosage forms.
About the RoleThis is a senior-level position that requires a strong background in pharmaceutical research and development, with expertise in developing generic solid oral formulations. The ideal candidate will have a master's degree in pharmacy or a related field and at least 13 years of experience in the generic pharmaceutical industry, or a Ph.D. with a minimum of 5 years of relevant experience.
Key Responsibilities- Develop robust formulations and processes for immediate release and modified release tablet and capsule dosage forms.
- Evaluate patents and develop non-infringement strategies, capable of developing Paragraph IV products.
- Scale-up and optimization of manufacturing process; execution of pre-exhibit and exhibit batches; scale up and technology transfer from R&D to production to meet timelines.
- Plan and contribute to project-related scientific/technical activities, including interpretation of results, critical assessment of data, drawing relevant conclusions, and writing reports.
- Autor technical documents, including Product Development Report, Quality Overall Summary, and other relevant documents for regulatory filing purposes.
- Master's degree in pharmacy or a related field, with a minimum of 13 years of experience in the generic pharmaceutical industry, or a Ph.D. with a minimum of 5 years of relevant experience.
- Proven track record of success in ANDA submissions, with experience in modified release dosage forms being a plus.
- Excellent written and verbal communication skills, as well as good interpersonal and project management skills.
We offer a competitive salary range of $180,000 - $220,000 per year, depending on experience, as well as a comprehensive benefits package, including health insurance, retirement plan, and paid time off.
