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Senior Research Associate - Formulations R&D
LOCATION

Hyderabad, India

DEPARTMENT

Formulations

Key Responsibilities:

  • Responsible for the development of new products and optimization of existing formulas; product lines including solid dosage products (tablets, capsules) and other delivery forms (eg, liquids, powders) for regulated markets like US, Europe and ROW.
  • Responsible for formulation and process development of oral dosage forms, including oral solid and liquid formulations. Troubleshooting and problem-solving of unresolved or new formula issues.
  • Design and execute formulation trials and evaluate stability data to finalize formulation composition.
  • Develop manufacturing processes for R&D formulations so that the technical transfer is successful for large-scale batches.
  • Write/review master formulas, manufacturing procedures, SOPs, stability protocols/reports, process validation protocols/reports, Product Development Reports, QOS, etc.
  • Works with Analytical Method Development, Regulatory Affairs, Quality Control, Quality Assurance, Inventory Control, etc. to expedite the development and approval of new products by the FDA.
  • Candidate should have hands-on/practical experience in development, technology transfer, and ANDA submissions for solid/ liquid oral dosage forms (solutions, suspensions, tablets, capsules) for regulated and semi-regulated markets like the US, Europe, and ROW.


Required Educational Qualification and Relevant Experience:

  • Minimum Master's Degree in Pharmaceutical Sciences with 4 Years of relevant experience.
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