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Product Development, Sr. Scientist I
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- Our Product Development laboratory located in our Monmouth Junction, NJ headquarters has an immediate need for an experienced PD Senior Scientist.
- The Product Development (PD) Senior Scientist I, under minimal guidance, designs, plans and conducts pre-formulation, formulation and process development activities as well as scale-up trials of complex projects using risk-based approach.
- Utilizes risk-based approaches and Quality by Design (QbD) principles in guiding pharmaceutical development and identifying critical quality attributes (CQA), critical material attributes (CMA), critical process parameters (CPP) and control strategies.
- Authors regulatory submission documents for New Drug Application (NDA)/Abbreviated New Drug Application (ANDA), supplements, annual reports and Investigator Responses (IR)/Complete Response Letters (CRLs), covering pharmaceutical development and manufacture, including product development reports
- Bachelors degree in Pharmaceutical Science or related scientific field and minimum 10 years experience in pharmaceutical formulation and product development
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