Sr Manager - Downstream Process

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

Job summary

Sun Pharma seeks a Biotech professional with hands-on experience in microbial cell culture and recombinant protein downstream processes. The role focuses on recovery, purification, and scale-up activities for biotech products under regulatory compliance.

Responsibilities include managing downstream operations, chromatography, TFF, filtration, tech transfer to pilot plants, and ensuring GMP/ISO standards. Strong problem solving and process optimization skills are essential.

Qualifications

• 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

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

Skills

Microbial cell culture

Recombinant protein

Downstream process

Automated chromatography

TFF and filtration systems

Process validation (downstream)

Technology transfer

Regulatory compliance

GMP/GDP/ISO knowledge

Problem solving

Education

Biotechnology background

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.