- Having versatile experience in the manufacturing unit of Inhalers & similar formulation
- Evaluation of suppliers of outsourced active drug substances, HPLC columns, instrument accessories, and consumables
- Analytical method development for assay, related substances, and particle size of nasal sprays and solutions, cosmetic sprays, metered-dose inhalers, suspensions, and API using HPLC or other techniques.
- Development of pMDI characterization methods (e.g. NGI, DUSA, the total can assay, moisture by Karl Fischer, foreign particulate matter, spray pattern, plume geometry, etc.)
- Stability testing studies on drugs, MDIs, Nasal spray, solution and suspension, and estimate shelf life.
- Generation of Standard Test Procedures and Specifications for raw materials, excipients, finished products, analytical method validation protocol, and reports.
- Reverse Engineering of competitor drug products.
- Ensure analytical method validation of developed products before its commercialization.
- Handhold with functional areas such as Purchase, Quality Control, Regulatory, F and D, manufacturing, business development, and external customers to ensure successful activities to meet developmental timelines.
- Active participation during formulation development and troubleshooting at quality control.
- Setting key result areas for subordinates and conducting semi and annual performance appraisals
- To raise, present, and getting approved the Opex and Revenue budgets.
- Nasal sprays and solutions, cosmetic sprays, metered-dose inhalers, etc. from concept to final launch (raw material evaluation, method development, prototype development support, stability study, responding customer based and regulatory queries, troubleshooting at the plant, method validation, etc.) to all Aerotech formulations of the division.
- Having good communication skills, Both written and verbal
- Well versed and updated with knowledge of regulations in Domestic as well as Regulated Markets.
Qualification: B.Sc/B.Pharma, MS/M.Sc/M.Pharma/MD-Ayurveda
Experience: 5-10 Years (RA- up to 4 Yrs, Executive – <6 yrs, Manager < 12 Yrs)