Sr Manager - Downstream Process

Sun Pharma; Bengaluru; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Sun Pharma is seeking a biotech professional with hands-on experience in microbial cell culture and recombinant protein downstream processing. The role emphasizes development, manufacturing activities under strict regulatory compliance, and process optimization to improve yields.

The candidate should be versed in automated chromatography, TFF, filtration systems, and tech transfer from R&D to pilot plant manufacturing, ensuring compliance with GMP/GDP/ISO standards.

Qualifications

• Candidates from Biotechnology Background with core experience in Biotechnology.

Responsibilities

• The incumbent must have experienced working on microbial cell culture, recombinant protein especially in the area of downstream process.
• Should have experience in handling 100L of harvest for downstream processing.
• Sound knowledge in operation of automated chromatography, TFF and filtration systems.
• To perform developmental and manufacturing activities as required for developing biotech products under regulatory compliance.
• Should be well versed with optimisation of process and robust execution of the same.
• To make the consistency batches with increased the yield.
• Experience on process validation downstream and developments for different methodologies for purification
• Assimilation of technology for process optimization, scale-up and validation studies for Bio-manufacturing of Phase III products.
• Good knowledge of technology transfer from R&D to Pilot plant manufacturing.
• Verification, review and production approval of master formula, batch and lot records, protocols pertaining to drug substance and drug product.
• Good knowledge on Regulatory, GMP, GDP and ISO guidelines, coordination with other departments for generation of polices, imparting training to departmental personnel, including risk assessments for facility and for products.
• Strategic thinking, Problem solving and decision making

Job description

Role & responsibilities

• The incumbent must have experienced working on microbial cell culture, recombinant protein especially in the area of downstream process.
• Should have experience in handling 100L of harvest for downstream processing.
• Sound knowledge in operation of automated chromatography, TFF and filtration systems.
• To perform developmental and manufacturing activities as required for developing biotech products under regulatory compliance.
• Should be well versed with optimisation of process and robust execution of the same.
• To make the consistency batches with increased the yield.
• Experience on process validation downstream and developments for different methodologies for purification
• Assimilation of technology for process optimization, scale-up and validation studies for Bio-manufacturing of Phase III products.
• Good knowledge of technology transfer from R&D to Pilot plant manufacturing.
• Verification, review and production approval of master formula, batch and lot records, protocols pertaining to drug substance and drug product.
• Good knowledge on Regulatory, GMP, GDP and ISO guidelines, coordination with other departments for generation of polices, imparting training to departmental personnel, including risk assessments for facility and for products.
• Strategic thinking, Problem solving and decision making

Preferred candidate profile

Candidates from Biotechnology Background with core experience in Biotechnology.