Sr Manager - Downstream Process

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.