Principal Scientific Manager

1 week ago


Hyderabad, Telangana, India Aragen Bioscience Full time
Job Summary

Aragen Bioscience seeks a highly skilled Principal Scientific Manager to lead the development of oral solid dosage forms of Non-DEA and DEA substances.

Key Responsibilities
  • Develop and implement pre-formulation, formulation design, and development of stable, bioequivalent, and manufacturable generic solid oral formulations.
  • Collaborate with cross-functional teams to execute change controls associated with manufacturing and packaging master records, SOPs, and protocols.
  • Author technical documents, including product development reports, quality overall summaries, and other relevant documents for regulatory filing purposes.
  • Evaluate patents and develop non-infringement strategies, capable of developing Paragraph IV products.
  • Scale-up and optimize manufacturing processes, execute pre-exhibit and exhibit batches, and scale up and technology transfer from R&D to production.
  • Plan and contribute to project-related scientific and technical activities, including result interpretation, data critical assessment, and relevant conclusion drawing.
  • Interaction with API manufacturers, CROs, and CMOs as needed.
Requirements
  • Master's degree in Pharmacy, with a minimum of 15 years of relevant experience in oral solids product development in the generic pharmaceutical industry.
  • Ph.D. degree in Pharmacy with a minimum of 5 years of relevant experience.
  • Successful track record of AND submissions is a must.
  • Excellent written and verbal communication skills, as well as good interpersonal and project management skills.

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