
Website Zydus Group Ltd
Post Name: Research Scientist- F&D
Job Location: PTC Moraiya
Experience range: 7-10 yrs
Role: Formulation Development of Injectable Products – US Market
Job Description:
To develop allocated product for the regulatory markets such as USA, Europe and other markets (as per requirement)
To undertake development of various injectable products which includes, but not limited to, drug device combination products, peptide/oligonucleotide-based products, Suspensions, Liposomes/Micelles, Lyophilized products, 505 (b)(2) products
To initiate sourcing and procurement of resources such as Active Pharmaceutical Ingredients (API), Excipients, Packaging material and other logistics required for formulation development.
To plan and execute various development trials for the allocated project in formulation laboratory along with online recording of experiments and data compilation.
To carry out stability studies of projects as per the project requirement and regulatory guidelines.
To prepare and execute supporting studies as per specific product requirement such as thermal cycling study, photostability study, dilution, reconstitution, etc.
Preparation of Master documents required for Scale-up and Exhibit batches such as Technology Transfer Documents (TTD), Master Formula Card (MFC), Stability Proposal, supporting studies protocols and other documents as per product requirements.
Execution of Scale up and Exhibit batches and preparation of summary reports in collaboration with CFT members & plant team.
To prepare submission documents such as Product Development Report (PDR), Extractable and Leachable Report (E&L) and other supporting studies reports as per product requirement.
Note: Interested candidates may share their CV with Pavan.sharma@zyduslife.com or can apply through ZTMP on Darwin.