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Scientific Manager - Formulations R&D

Scientific Manager - Formulations R&D

Aragen Biosciencehyderabad, India
13 hours ago
Job description

Key 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.

Responsibilities :

  • Candidate must be a good mentor and motivator.
  • Develop robust formulationsand processes for immediate release and modified release tablet and capsuledosage forms.
  • Evaluate patents anddevelop non-infringement strategies. Capable of developing Paragraph IVproducts.
  • Scale-up and optimizationof manufacturing process; execution of pre-exhibit and exhibit batches; scaleup and technology transfer from R&D to production to meet timelines.
  • Plan and contribute toproject-related scientific / technical activities (e.g., interpret results,critical assessment of data, draw relevant conclusions, and write reports).
  • Author technical documentsincluding Product Development Report, Quality Overall Summary and otherrelevant documents for regulatory filing purpose.
  • Interaction with APImanufacturers, CROs and CMOs as needed.
  • Work proactively with othercross-functional groups to execute change controls associated withManufacturing and Packaging master records, SOPs and protocols.
  • Create and review SOPs, aswell as review appropriate documentation and test results for accuracy andcompleteness and compliance with SOPs / GMP requirement.
  • Coordinate with RA forfiling ANDAs and addressing deficiencies; provide relevant documents toRegulatory 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 and Relevant Experience :

  • Master’s with a minimum of10 years or a Ph.D. degree in Pharmacy with a minimum of 5 years of relevantexperience in oral solids product development in generic pharmaceuticalindustry. Generic R&D experience and successful track record of ANDsubmissions is a must. Experience with modified release dosage forms is aplus. Candidates must be self motivated with excellent written and verbalcommunication skills. Good interpersonal and project management skills arecritical for this position.
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    Manager • hyderabad, India