Research Scientist- MS&T (OSD)

Alembic Pharmaceuticals

1 - 6 years

3 - 6 Lacs

vadodara

Posted:3 weeks ago| Platform:

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Skills Required

technology transfer scale up process development exhibit batches tech transfer msat

Work Mode

Work from Office

Job Type

Full Time

Job Description

Role & responsibilities

Review and provide technical inputs on Product Development Reports (PDR), Master Formula Cards (MFC), and Technology Transfer (TT) documents.
Prepare product process-related risk assessments, protocols, and reports for feasibility trials and scale-up batches.
Execute trial and scale-up batches, and prepare summary reports.
Prepare and review Exhibit Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR).
Support regulatory filing by providing intended commercial BMR, BPR, and stability evaluation summaries.
Support regulatory in obtaining Test Licenses, Import Licenses, No Objection Certificates (NOC), and Manufacturing Licenses by providing the necessary product and process-related documents.
Review and provide Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs) as part of the Annual Product Review.
Initiate New Product Introduction (NPI) procedures for new product manufacturing at the site.
Responsible for implementation of Process Analytical Technology (PAT) at the manufacturing facility for process improvement.
Exposure and experience in working on Injectable/Parenteral and Oncology projects.
Review and provide technical inputs on PDR, MFC, and TT documents.
Prepare product process-related risk assessments.
Prepare and review Exhibit BMR and BPR.
Initiate NPI procedures for new product manufacturing at the site.
Support regulatory filing by providing intended commercial BMR, BPR, and stability execution summaries.
Prepare Standard Operating Procedures (SOPs).
Prepare position papers, justification reports, and technical reports.

Position based at Formulation site- 40 Kms. away from Vadodara city.

Preferred candidate profile

B.Pharm or M.Pharm

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