GLAND PHARMA LIMITED – Hiring Formulation R&D – Injectables
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.
Vacancy Details Below:
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 email@example.com