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Gland Pharma hiring for Formulation R&D Injectables Departments at Hyderabad location
- To perform pre – formulation and formulation development trials using QbD approach and to develop a robust formulation.
- Interact with cross functionally across departments and ensure timely submission and approval of the assigned projects as per agreed work plan.
- Navigate the project technically and provide feasible technical solutions so as to develop a product recipe that can be successfully manufactured post approval.
- Conduct literature search and evaluate patent landscape for assigned project and work out the pathway for least time to effect successful submission.
- Planning and execution of lab scale batches and stability batches and documentation of the same in Lab Note Book.
- To ensure successful scale up / exhibit batches at plant.
- Preparation of protocol and report for trial batches and execution of the development study accordingly.
- Preparation of Development Study Report after receipt of COAs.
- Preparation of Stability protocol and charge stability batches as per the protocol.
- Compilation of stability data as per ICH guidelines.
- To prepare Technology Transfer documents like MPS, MF and Risk Assessment Reports.
- To prepare Product Development Report based on studies performed and available COA for regulatory submission.
- Troubleshooting of existing commercial products.
- To be a part of Equipment / Instrument Qualification activity in case of procurement of any new Equipment / Instrument and prepare and review qualification documents.
- To co-ordinate with cross functional departments like ARD, RA, QA, Production for project / product related activity.
- Qualification: M Pharm in Pharmaceutics/Pharmaceutical Technology Formulations
- Department: Formulation R&D – Injectables
- Location: Hyderabad
- Benefits: Five days working
- Preferred Experience: 1-6 years in Injectables
About Gland Pharma:
We are present in sterile injectables, oncology and ophthalmic segments, and focus on complex injectables including NCE-1s, First-to-File products and 505(b)(2) filings. Our products are currently delivered via liquid vials, lyophilized vials, pre-filled syringes, ampoules, bags and drops; and efforts are underway to augment additional manufacturing capabilities in complex injectables such as peptides, long-acting injectables, suspensions and hormonal products.
A glimpse about Gland Pharma: https://youtu.be/p3y2UTTXTQA
Link to our website: https://glandpharma.com/
Interested candidates can share their CVs on ketangoud.bathula@glandpharma.com
