Executive/ Junior Executive - Downstream Manufacturing ( mAbs)

Kemwell; Bengaluru; On-site; INR 600,000 - 1,200,000; Full time

Job summary

Kemwell is seeking committed professionals for their Downstream Processing (DSP) Manufacturing team in Bengaluru, India. Suitable candidates will be considered for roles ranging from Junior Executive to Senior Executive with a requirement of 12 years of relevant experience.

The selected candidates will be responsible for executing DSP manufacturing activities according to approved SOPs, ensuring compliance with GMP standards, and supporting technology transfer. A graduation or post-graduation in a relevant science discipline is essential.

Qualifications

• 12 years of relevant experience in DSP manufacturing.
• Experience in monoclonal antibody (mAb) manufacturing 400L & 2KL is preferred.
• Willingness to work in shift operations.

Responsibilities

• Execute routine DSP manufacturing activities as per approved SOPs.
• Maintain compliance with GMP and quality systems.
• Support technology transfer and process validation activities.

Skills

Hands-on experience in DSP operations

Good communication and documentation skills

Strong understanding of GMP and aseptic practices

Ability to work in a cross-functional environment

Education

Graduation or post-graduation in relevant science disciplines

Job description

We are looking for committed professionals to join our Downstream Processing (DSP) Manufacturing team. Candidates with 12 years of relevant experience will be considered for roles across Junior Executive, Executive, and Senior Executive levels.

Key Responsibilities

• Execute routine DSP manufacturing activities on the shop floor as per approved SOPs and Batch Manufacturing Records.
• Schedule and execute daily manufacturing operations in assigned shifts, including operation of automated process vessels, chromatography systems , chromatography columns, TFF systems, viral filtrations and formulation activities.
• Maintain DSP manufacturing areas in compliance with GMP and quality systems.
• Assemble, prepare, and operate manufacturing equipment.
• Support technology transfer, process scale-up, and process validation activities.
• Coordinate with QA and Engineering to ensure GMP compliance and equipment upkeep.
• Ensure timely completion of training requirements and maintenance of technical competency.
• Operate and maintain common DSP equipment including Autoclave, Central CIP, Hot Air Oven, FIT machine, Cold Rooms, CLAF, Dispensing Booths, biowelder, bio sealer meter, weighing balance, turbidity meter.
• Execute technical protocols, solution preparation records, solution preparation records, and manufacturing documentation.
• Support investigations related to deviations and contribute to continuous improvement initiatives.
• Adhere to EHS guidelines and ensure workplace safety.

Key Requirements / Desired Profile

• Hands-on experience in DSP operations, preferably monoclonal antibody (mAb) manufacturing 400L & 2KL.
• Willingness to work in shift operations.
• Good communication and documentation skills.
• Strong understanding of GMP, data integrity, and aseptic practices.
• Ability to work effectively in a cross-functional manufacturing environment.
• Experience in handling shop-floor teams (for Executive / Senior Executive roles).

Education Qualification

• Graduation or post-graduation in a relevant science discipline (Biotechnology, Biochemistry, Microbiology or related fields).