Aurobindo Research Center- II Job Vacancy for Team Leader
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/suspensions 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 Application of DOE and factorial design in formulation strategy, CPP etc.
development for process and formulation optimization.
Pre-formulation studies, lab scale development, Scale up, Pre-exhibit, 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, data compilation review of data.
To maintain of 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 skill set can share their updated profile to
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