Senior Executive
Rubicon Research Limited
Position / Job Title - Senior Executive
Department - Formulation Development
Reporting To - Senior Manager
Location - Thane
Years of Experience- 8 to 12 years
Dosage Form - Solid & Liquid Oral, Pellets, MUPS
Job Responsibilities / Deliverables
- 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.
- To effectively plan & coordinate execution of lab scale up/ optimization and pilot BE batches by ensuring strict adherence to lab GMP system and practices.
- Timely review of Lab experiment notebooks as well as preparation and review of technology transfer documents
- 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.
- 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 cGMPs.
- Master in pharmacy (Pharmaceutics)
- Must-Have Skills: Formulation development experience of Solid & Liquid Oral and pellets; preferred to have Novel drug delivery project experience.
- Role is expected to work in extended hours/any of the shift based on the requirement.
- Expected to visit manufacturing sites, whenever required.