Dr Reddy’s MTech/MSc Bioprocess Technology & Biotechnology R&D Job

Dr. Reddy’s Laboratories Ltd. is looking for MTech/MSc in Bioprocess Technology/ Biotechnology candidates for MSAT Specialist Upstream with Biologics Unit, Hyderabad. Interested candidates may check out the details on Dr. Reddy’s job mentioned below:

Position Details: MSAT Specialist Upstream with Biologics Unit

Employment Type: Full Time, Permanent

Salary: INR 8,00,000 – 14,00,000 PA.

Job Location: Hyderabad

Education: MTech/MSc in Bioprocess Technology/ Biotechnology / with Masters/Bachelor’s Degree in Chemical Engineering

Experience: 3+ years of post-qualification experience in API or Pharma industry in new technologies and PAT tools area. Any experience in operational excellence and Six Sigma methodology will be an added advantage.

Job Description

• Participate in Scale-up of the process from Pilot Plant/ R & D to the manufacturing facility in close coordination with Pilot plant/R & D and Manufacturing team
• Identify and highlight scale-up issues/Post-scale-up issues and suggest remedial measures before tech transfer
• Responsible for review of development report and acceptance of process from Pilot plant
• Responsible for successful scale-up of processes and its troubleshooting where ever needed
• Responsible for ensuring manufacturability of the process from point of view of process robustness, material availability and costing
• Lead investigation for deviations using various available tools like RCA, Fishbone analysis, etc.
• Provide strategic directions in investigating deviations, out of trend and Out of specification to suggests a robust CAPA
• Use tools to identify CPPs and CQAs to improve the process robustness and yield
• Participate in Process Characterization and preparation/review of Process Validation protocol/report
•Participate in continuous process verification of the commercial process on a regular basis using available tools and prepare the required documents for the same.
•Provide technical inputs for Facility and Layout design, equipment selection
• Co-ordinate effectively across teams to resolve a complex issue and drive new initiatives with a concerted effort
• Participate in investigating any customer complaint from a technical point of view
• Implement the use of new technologies depending on the latest industry updates and best practices

Roles and Responsibilities
1. Process scale-up From R& D / Pilot to manufacturing facility

  • Monitoring lab batches,
  • scale-up studies,
  • safety & effluent data generation etc. Process scale-up studies in R&D lab through necessary protocols/reports.
  • Making material balance and quality mapping at lab scale

2. Manufacturing process support

  • Participate actively in major and critical deviations investigation.
  • Support for the right CAPA identification and involvement in the implementation
  • Troubleshoot at manufacturing unit operation and perform additional studies if required.

3. Preparation of safety & Quality documentations Implement Documentation Practices as per the company’s quality policy; ensure that compliance (regulatory, statutory and legal) are understood,
Ensuring the team for preparation all PSM documentation, supporting documents for trail & validation, technical closure reports etc. Ensuring the preparation of Technical justifications, closure reports, Investigation report etc.

4. Continuous Process Verification
1. Conduct CPV for the products in the manufacturing facility on a regular basis.
2. Investigation of OOS/ OOT
3. Ensure the process is within control limits

New Technology Implementation

Assess new technology for the available products which is more efficient operationally and cost-effective

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