Senior Executive- Pulmonary R&d Job in Gennext India Private Limited
Senior Executive- Pulmonary R&d
Gennext India Private Limited
4+ weeks ago
- Pune, Pune Division, Maharashtra
- Not Disclosed
- Full-time
- Permanent
Job Summary
2. Responsible for API characterization, particle engineering and checking of formulation feasibility.
3. Responsible for development, optimization of pMDI/DPI formulation & process through QbD approach.
4. To contribute in developing and optimizing Inhaler device for pMDI/DPI application. To compile design history files
5. Responsible for data interpretation, preparation of development Report, Technology transfer documents, Drug product characterization reports & IVBE reports
6. Responsible for Technology transfer, process standardization for scaleup/exhibit stage at production plant.
7. Having knowledge on the pMDI & DPI equipment s at lab scale & commercial scale (Eg. Pressurized mixing vessel, homogenizer, filling equipment s (single stage & two stage filling), low shear/High shear blender, Micro dose filling system (Capsule/Blister based), blister packaging machine etc.
8. Trouble shooting of product at commercial manufacturing location.
9. Experience in Formulation Development of pMDI/DPI for Advanced markets
10. Experience in Operation & Calibration of various formulation equipments specific to pMDI/DPI application.
11. Thorough knowledge in QbD approach, FDA, MHRA, EMEA, TGA & ICH guidelines, Combination product guidance pertaining to CFR 820, ISO 13485 etc.
12. Experience in Statistical tools (Mini Tab, Design expert, Slimstat etc)
13. Result Oriented & Good Interpersonal/Communication skills
Roles and Responsibilities
1.Responsible for Literature Search. (Including Patents) and Preparation of Development Strategy for pMDI/DPI formulation.2. Responsible for API characterization, particle engineering and checking of formulation feasibility.
3. Responsible for development, optimization of pMDI/DPI formulation & process through QbD approach.
4. To contribute in developing and optimizing Inhaler device for pMDI/DPI application. To compile design history files
5. Responsible for data interpretation, preparation of development Report, Technology transfer documents, Drug product characterization reports & IVBE reports
6. Responsible for Technology transfer, process standardization for scaleup/exhibit stage at production plant.
7. Having knowledge on the pMDI & DPI equipment s at lab scale & commercial scale (Eg. Pressurized mixing vessel, homogenizer, filling equipment s (single stage & two stage filling), low shear/High shear blender, Micro dose filling system (Capsule/Blister based), blister packaging machine etc.
8. Trouble shooting of product at commercial manufacturing location.
9. Experience in Formulation Development of pMDI/DPI for Advanced markets
10. Experience in Operation & Calibration of various formulation equipments specific to pMDI/DPI application.
11. Thorough knowledge in QbD approach, FDA, MHRA, EMEA, TGA & ICH guidelines, Combination product guidance pertaining to CFR 820, ISO 13485 etc.
12. Experience in Statistical tools (Mini Tab, Design expert, Slimstat etc)
13. Result Oriented & Good Interpersonal/Communication skills
Experience Required :
4 to 9 Years
Vacancy :
2 - 4 Hires
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