Aurobindo Research Centre - II at Pashamaylaram, Hyderabad location is looking for:
Role: Team Leader
Department: Nasal - Formulation Development
Experience: 8 to 14 Yrs.
Required Skill Set: End-to-end development and manufacturing of UNIT DOSE/BI DOSE NASAL SPRAY PRODUCT.
Job Role:
- Literature search, patent search, reference product information and other literature related to formulation and excipients for product development strategy.
- Formulation Development of Nasal spray solutions/suspension dosage forms for US, Europe, ROW and other regulated markets.
- Development of Q1, Q2 formulation and device according to regulatory guidelines.
- Preparation and evaluation of QTPP, CQA, CMA-DS, Control strategy, CPP etc.
- Application of DOE and factorial design in formulation development for process and formulation optimization.
- Pre-formulation studies, lab-scale development, Scale-up, Pre-exhibit, and Exhibit Batches (Technology Transfer) planning and execution.
- To prepare of stability protocol, sampling protocols, Master formula card, BPR, TTD documents & PDR report.
- To maintain logbooks for day-to-day activities, LNB writing, sample submission, and data compilation review of data.
- To maintain calibration/maintenance schedules, BOM, API justification, RLD justification, etc.
- Planning and conducting In-vitro testing, In-vivo Bio-equivalence study as per regulatory requirements (In-vitro, PK and PD) for Nasal spray products.
- To handling regulatory queries/ market complaints from various regulatory agencies.
- To comply with departmental SOPs & working instructions of various equipment and maintain related records.
- To comply with the guidelines for managing the laboratory including the safety, security and maintenance of the equipment.
Interested people with relevant skillset can share their updated profile to Santhikiran.kurra@aurobindo.com
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