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Principal Scientific Manager - Pre Formulations

Principal Scientific Manager - Pre Formulations

Aragen BioscienceHyderabad, India
30+ days ago
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 groups to execute change controls associated with Manufacturing and Packaging master records, SOPs and protocols.
  • Create and review SOPs, as well as review appropriate documentation and test results for accuracy and completeness and compliance with SOPs / GMP requirement.
  • Coordinate with RA for filing ANDAs and addressing deficiencies; provide relevant documents to Regulatory Affairs in a timely manner for ANDA filings and Supplements filing.
  • Review of batch records, process characterization reports, validation reports and investigation reports.

Required Educational Qualification & Relevant Experience :

  • Masters with a minimum of 15 years or a Ph.D. degree in Pharmacy with a minimum 5 years of relevant experience in oral solids product development in generic pharmaceutical industry. Generic R&D experience and successful track record of AND submissions is a must. Experience with modified release dosage forms is a plus. Candidates must be self motivated with excellent written and verbal communication skills. Good interpersonal and project management skills are critical for this position.

    • Functions :

  • Responsible for development of oral solid dosage forms of Non-DEA and DEA substances, Literature Search, Pre-Formulation, Formulation Design, and Development of stable, Bioequivalent and Manufacturable Generic Solid Oral Formulations.