Scientist

Research Scientist- Biologics @chennai Full Time

Qualifications:

PhD or MSc in Lifesciences/Biotechnology or related field

At least 5-10 years experience in Cell and Tissue manufacturing, including GMP environment.

Demonstrated experience in an research and development/manufacturing role is highly required

Must Have - Lyophiliser Work Experience

Key Responsibilities:

• Responsible for new product development, scale up of successful R&D batches & transfer of technology to commercial batches
• Implementation of new product development process.
• Answering regulatory related queries within lead time
• Review regular basis stability studies protocol and reports
• Document preparation (PDR, MFR,PV,Stability) for regulatory dossiers
• Developing the quality of product with cost effectiveness
• Training the formulators for literature study before development & conduct patent search
• Achieving development target of sample product for registration of export samples as well as domestic samples
• Checking all Project In Process Data, COA & Log books of all project members.
• Fulfil requirement of MFR, BMR & Tech Transfer Products.
• Reducing development costs & product cost
• Resolve trouble shooting in production during scale up and commercial batches
• Customized sampling for different customer
• Review process validation and analytical validation protocols and reports
• Providing information for vendor management approval system
• Leading the entire department

Competencies Required:

• Aseptic processing techniques.
• GMP working knowledge.
• Human tissue and cell handling techniques.
• Closed loop operations.
• Cell expansion techniques.
• Process equipment handling like Biosafety cabinets,Lyophilizer, filling etc.

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