Manager Upstream BM Production Biotechnology

Sun Pharma; Hoskote; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Sun Pharma in Karnataka seeks an experienced bioprocess manufacturing lead to oversee microbial cell culture operations, scale-up, and tech transfer. You will manage 1000L bioreactor production, CIP/TFF systems, and drive GMP/GLP-compliant processes across cross-functional teams.

The role requires hands-on experience with scale-up, equipment qualification, and delivering cost/time improvements while ensuring regulatory compliance with ICH, USFDA and CDSCO guidelines.

Qualifications

• Experience with 1000L bioreactor manufacturing and automated CIP/TFF systems.
• Experience in manufacturing consistency and commercial-scale up batches.
• Experience in technology transfer from R&D to commercial plant manufacturing.
• Qualification of equipment and facilities.
• Solid GMP knowledge and working with cross-functional teams for timely execution.
• Familiarity with regulatory guidelines ICH, USFDA and CDSCO.
• Ability to lead, motivate and train teams in GMP/GLP areas.
• Ability to implement process steps for cost and time savings.

Responsibilities

• Manufacture on a 1000L bioreactor and operate CIP, CIP and TFF systems.
• Handle consistency and commercial-scale-up batches.
• Lead technology transfer from R&D to commercial manufacturing.
• Ensure qualification of equipment and facilities.
• Maintain GMP and GLP compliance with cross-functional teams.
• Lead, motivate, and train the team in GMP/GLP areas.
• Implement process steps for cost and time savings.

Skills

Team leadership

Problem solving

Decision making

Strategic thinking

Regulatory knowledge

Job description

Role & responsibilities

The incumbent must have experienced working on microbial cell culture, recombinant antibody manufacturing from microbial expression systems.

• Should have experience in manufacturing on 1000L bioreactor and handling automated CIP, CIP and TFF systems.
• Experience on manufacturing of consistency and commercial scale up batches.
• Good knowledge of technology transfer from R&D scale to commercial plant manufacturing.
• Should be responsible for qualification of equipment's and facility.
• Sound knowledge on GMP and working in close with cross functional departments for execution of manufacturing activities within specified timelines.
• Should lead, motivate and train the team in GMP and GLP specified areas. Well acquainted with regulatory guidelines ICH, USFDA and CDSCO.
• Should have strategic thinking, Problem solving and decision making.
• Should able to implement process steps for cost and time saving.

Preferred candidate profile

Candidates With Hands on work Experience in Biotech Pharma Industry will be preferred