Associate Scientist

Lupin; Pune District; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Lupin in Pune seeks a Process Development Engineer to advance peptide synthesis and API projects through development, lab scale-up, and technology transfer. You will engage in GLP-compliant lab work, plan experiments, and collaborate with cross-functional teams to ensure smooth transitions to manufacturing.

The role requires strong technical communication, meticulous execution, and flexibility to work in shifts as per project needs.

Responsibilities

• Experience in solid/liquid phase peptide synthesis, handling of DAC chromatography column, RP-HPLC, Ion Exchange; understanding of TFF and Lyophilization operations.
• Prepare URS and support DQ/IQ/OQ activities; involve in plant design considerations.
• Responsible for process development activities with focus on process engineering aspects for peptides, regular APIs, and CDMO molecules; support lifecycle from development through technology transfer.
• Involve in technical evaluation during lab development; plan and conduct experiments, perform literature surveys to support product w.r.t. project.
• Carry out experimental evaluation for scale-up activities; share proposals with CFT and support scientists during product technology transfer as per plan.
• Involve in scale-up activities of developed molecules at kilo lab and generate data for plant-scale scale-up.
• Perform daily activities per approved plan; follow GLP and SOPs; ensure safety adherence.
• Prepare technical and execution documents for project transfer to manufacturing plant and support during plant validation.
• Demonstrate good communication, precision in execution, and willingness to work in shifts as required.

Job description

Role & responsibilities

• 1. Experience in Solid/Liquid phase peptide synthesis, handling of DAC chromatography column, RP-HPLC, Ion Exchange etc., understanding of TFF and Lyophilization operations.
• 2. Preparation of URS, handling technical aspects during DQ, IQ, OQ activities, involve in plant design considerations.
• 3. Responsible for process development activities with a strong focus on process engineering aspects for Peptides, Regular APIs, and CDMO molecules, supporting the entire lifecycle from early development through technology transfer.
• 4. Involve in technical evaluation of every aspect during lab development phase of project, Plan and conduct experiments at lab wherever required and do necessary literature survey to support the ongoing work w.r.t product.
• 5. Carry out experimental evaluation from a technical perspective for scaleup activities, prepare and share proposals with the CFT and support scientists during product technology transfer as per the approved plan
• 6. Involve in the scale up activity of the developed molecules at kilo lab and should generate relevant data for further scale up at plant scale.
• 7. Perform daily activities as per the approved plan, strictly following GLP and relevant SOPs, and ensure adherence to all safety requirements defined in the SOPs
• 8. Prepare required technical and execution documents for project transfer to the manufacturing plant and provide support during plant validation activities
• 9. Demonstrate good communication skills, precision in execution, and readiness to work in shifts as per project and organizational requirements.