Hiring for Rubicon Research Recruiting For Officer – Formulation Development ( R and D )

Responsible for the development of new products and optimization of existing formulas; product lines including traditional solid dosage products (tablets, capsules) and other delivery forms (e.g. liquids, powders).

• Responsible for formulation and process development of oral dosage forms, including oral solid and liquid formulations. Troubleshoot and problem-solve unresolved or new formula issues.
• Design and execute formulation trials and evaluate stability data to finalize formulation composition.
• Develop robust manufacturing processes for R&D formulations so that the technical transfer is successful for large scale batches.
• Responsible for all formulation/ process related CMC documents which will be part of regulatory filings.
• Write/review master formulas, manufacturing procedures, SOPs, stability protocols/reports, process validation protocols/reports, Product Development Reports, QOS, QbR etc.
• Support the manufacturing of exhibit/submission batches per regulatory requirements.
• Support technology transfer for manufacturing processes from laboratory scale to production scale.
• Works with Analytical Method Development, Regulatory Affairs, Quality Control, Quality Assurance, Inventory Control, etc. to expedite the development and approval of new products by FDA.
• Assure that all formulation and process development activities are documented in the notebook as per company procedures and cGLPs.
• Provide recommendations for continuous improvements in practices and systems to improve performance and enhance efficiency and quality.

Qualifications & Pre-Requisites

• Masters Degree in Pharmaceutical sciences educational background with 1-3 years of experience in related field.
• Knowledge of regulatory guidances
• Exposure of pellet projects and liquid oral projects will be an added advantage for the role.

Concern Person

Pranali

[email protected]

HR Department