Senior Scientist, Product Development

Brunswick, NB, Canada

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Title: Senior Scientist, Product Development

Date: Aug 10, 2022

Location: New Brunswick - OHM

Company: Ohm Laboratories Inc , USA

Evaluate and help develop new platform technologies, suggest patentable, patent non-infringing and design around technologies for FTF and 505(b) (2) products as needed.
Provides scientific and technical leadership in developing new products
Conducts scientific literature search periodically on assigned projects
Independently design experimental plans, executes the studies for routine development, scale-up/s and exhibit batches.
Formulate and design drug products using QbD methodologies.
Analyzes data and performs root cause analysis in trouble shooting.
Participate in manufacturing of scale-up and Submission Batches
Prepare reports on project status, literature review, and technical issues and their resolution affecting the product development.
Prepare product development reports, process development report and other relevant documents as required for filing.
Understands timelines and demonstrates a sense of urgency in work and in responding to customers and colleagues.
Complete all required in-house and external training to keep current on regulatory and industry changes
Must be able to work in a cross-functional environment interacting with departments such as formulation, analytical, regulatory, biopharmaceutics, quality and project management

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