IPDO Executive / Senior Executive

Apitoria Pharma; Hyderabad; Vor Ort; INR 600.000 - 1.200.000; Vollzeit

Zusammenfassung

Apitoria Pharma is seeking a candidate to oversee and optimize lab processes, perform scale-up studies, and coordinate with cross-functional teams for process development. Responsibilities include observing experiments, data compilation, safety reporting, equipment mapping, and batch validations across kilo lab and pilot plant stages.

The role requires thorough documentation, collaboration with CRD and MF/Tech transfer teams, and generation of process safety reports for final PDR.

Aufgaben

• Observe the lab experiments from optimization of the process
• During observations, process modification considering scale up with agreement of CRD
• generating what-if/negative experiments data based on draft process & data compilation in PDR.
• Material Balance (with estimation of by-product quantities generation per Kg of product / input).
• Disposal procedures of by-products (data shall be generated from literature)
• Preparation of Environmental load report.
• Preparation of Scale up (Lab/Kilo lab/Pilot plant) report.
• Study critical process parameters
• Solvent recovery notes with solvent mass balance (which contains solvent streams being generated and their recovery possibility).
• Basic engineering document preparation and circulation to CFT (MF, Tech transfer team).
• Performing Coupon test (wherever required).
• After receiving the process, preparation of draft equipment mapping .
• Preparing and sharing Equipment mapping for Kilo lab / Pilot plant for developmental batches.
• Review of BPCR for pilot plant or Kilo lab
• Generate the process safety reports with the help of PE lab and making it part of final PDR.
• preparation & sign-off of equipment and MOC compatibility reports.
• Review the modification works in plant.
• RM requirement & Equipment mapping to be finalized in co-ordination with the plant team
• Trail batch execution along with plant team.
• Trial batch report closure along with plant team.
• Validations & Entire campaign batches Monitoring along with plant team.
• Project closure report along with the plant team.

Jobbeschreibung

Role & responsibilities :

1. Observe the lab experiments from optimization of the process
2. During observations, process modification considering scale up with agreement of CRD
3. generating what-if/negative experiments data based on draft process & data compilation in PDR.
4. Material Balance (with estimation of by-product quantities generation per Kg of product / input).
5. Disposal procedures of by-products (data shall be generated from literature)
6. Preparation of Environmental load report.
7. Preparation of Scale up (Lab/Kilo lab/Pilot plant) report.
8. Study critical process parameters
9. Solvent recovery notes with solvent mass balance (which contains solvent streams being generated and their recovery possibility).
10. Basic engineering document preparation and circulation to CFT (MF, Tech transfer team).
11. Performing Coupon test (wherever required).
12. After receiving the process, preparation of draft equipment mapping .
13. Preparing and sharing Equipment mapping for Kilo lab / Pilot plant for developmental batches.
14. Review of BPCR for pilot plant or Kilo lab
15. Generate the process safety reports with the help of PE lab and making it part of final PDR.
16. preparation & sign-off of equipment and MOC compatibility reports.
17. Review the modification works in plant.
18. RM requirement & Equipment mapping to be finalized in co-ordination with the plant team
19. Trail batch execution along with plant team.
20. Trial batch report closure along with plant team.
21. Validations & Entire campaign batches Monitoring along with plant team.
22. Project closure report along with the plant team.