Alembic Pharmaceuticals for Senior Research Scientist – Apply before 30th June 2024

Post: Senior Research Scientist – MS&T (Complex Injectables)

Job Description:

• Responsible for managing MS&T documentation activities.
• Prepare, issue, and maintain Standard Operating Procedures (SOPs).
• Initiate Vendor Qualification processes.
• Organize and coordinate Training Activities; maintain training records.
• Responsible for material code initiation.
• Assist in New Product Introduction (NPI) activities.
• Execute other assignments delegated by the Department Head.
• Initiate and close Change Controls from the MS&T Department.
• Initiate New Product Introduction forms for new products.
• Coordinate Scale-up, Trial, and Submission batches with Cross Functional Teams.
• Review and provide technical input on Product Development Reports (PDR), Master Formula Cards (MFC), and Technology Transfer (TT) documents.
• Conduct product process-related risk assessments.
• Prepare protocols and reports for feasibility trials and scale-up batches.
• Review Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR).
• Review Exhibit Batches Summary Reports.
• Support Process Validation (PV) batches and provide technical inputs.
• Support regulatory filings by providing necessary documentation.
• Review Critical Process Parameters (CPPs) and Critical Quality Attributes (CQA) for annual product reviews.

Candidate Profile:

• Bachelor’s or Master’s degree in Pharmacy (B.Pharm / M.Pharm) with a specialization in Pharmaceutics or Pharmaceutical Technology.
• 8 – 12 years of Technology Transfer Experience within the pharmaceutical industry.
• Prior experience in Injectable is essential.

Job Location: Vadodara, Gujarat
Last Date: 30th June 2024

Interested candidates can also share their CV at msnt@alembic.co.in

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