Job Description
Key Responsibilities:
Candidate must be a good mentor and motivator.
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 (e.g., interpret results, critical assessment of data, draw relevant conclusions, and write reports).
Author technical documents including Product Development Report, Quality Overall Summary and other relevant documents for regulatory filing purpose.
Interaction with API manufacturers, CROs and CMOs as needed.
Work proactively with other cross-functional ...
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