Sr. Scientist

Keka Technologies Private Limited; Sanand; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Keka Technologies Private Limited in Gujarat invites a seasoned process development professional to lead kilo lab activities, scale-up and technology transfer for new molecules to enable commercialization.

You will drive cross-functional collaboration with R&D, ADL, Production, QA, QC, EHS, and Supply Chain, ensuring GMP/GLP compliance, optimizing solvent recovery, and delivering robust, scalable processes.

Qualifications

• cGMP/GLP Compliance data integrity practices.
• Problem-solving and troubleshooting skills.
• Good communication and teamwork.
• Leadership and team management.

Responsibilities

• Lead kilo lab demonstrations and pilot-plant batch planning for new molecules.
• Execute API process tech transfer from R&D to manufacturing scale.
• Prepare and review scale-up reports, PFD, P&ID, SOPs, energy and mass balances.
• Support scale-up, validation batches, and commercialization.
• Evaluate CPP, IPC, and operating conditions for process robustness.
• Analyze batch data (yield, cycle time, quality trends) for continuous improvement.
• Ensure GMP, EHS, and global regulatory compliance.
• Optimize solvent recovery systems to improve yield and reduce solvent use.
• Provide on-floor technical support during critical operations and scale-up.
• Drive process optimization and debottlenecking for capacity.
• Identify innovative technologies and cost-reduction strategies.
• Coordinate cross-functionally with R&D, ADL, Production, QA, QC, Engineering, EHS, and Supply Chain.
• Introduce process improvements at commercial scale to reduce costs.
• Conduct HAZOP, HIRA, and product risk assessments for safe scale-up.
• Promote teamwork, accountability, and continuous improvement.
• Ensure strict adherence to EH&S policies.

Skills

cGMP/GLP Compliance

Problem-solving

Communication

Leadership

Job description

• (1) Scaleup & Technology transfer


• (2) Kilo Lab Activities


• (3) Process improvement projects & capacity expansion


• (4) Implementation of new technology


• (5) Cross-Functional Collaboration

• Lead laboratory demonstration, Kilo Lab, and pilot plant batch planning & execution for new molecules, ensuring technical feasibility prior to commercialization


• Execute technology transfer of API processes from R&D to commercial manufacturing scale


• Prepare and review critical technical documents including Scale-up Reports, PFD, P&ID, BPR, SOPs, Energy balance, Mass balance, raw material norms, process cycle time, and risk assessments


• Support scale-up, exhibit, and process validation batches to ensure successful commercialization


• Evaluate critical process parameters (CPP), in-process controls (IPC), and operating conditions to ensure process robustness


• Collect, analyze, and interpret batch data (yield, cycle time, quality trends) for continuous improvement


• Ensure compliance with GMP, EHS, and global regulatory requirements


• Optimize and monitor solvent recovery systems (distillation, recycling, reuse) to improve yield, reduce solvent consumption, and minimize environmental impact


• Provide on-floor technical support during critical operations, troubleshooting, and scale-up activities


• Drive process optimization and debottlenecking initiatives to enhance plant capacity utilization


• Identify and implement innovative technologies and cost-reduction strategies to improve efficiency and reduce raw material consumption


• Coordinate cross-functionally with R&D, ADL, Production, QA, QC, Engineering, EHS, and Supply Chain for seamless execution of projects


• Introduce and implement process improvements at commercial scale to enhance productivity and reduce manufacturing costs


• Conduct HAZOP, HIRA, and product risk assessments to ensure safe and reliable scale-up


• Promote a culture of teamwork, accountability, and continuous improvement within the department

Ensure strict adherence to environmental, health, and safety policies and best practices

Required Skills

cGMP & GLP Compliance data integrity practices Problem-solving & troubleshooting skills Good communication and teamwork Leadership & Team Management