15 Aug
|
SUN PHARMA
|
Bengaluru
15 Aug
SUN PHARMA
Bengaluru
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.
Positive 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.
Positive 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.
📌 Sr Manager Downstream Process Bengaluru
🏢 SUN PHARMA
📍 Bengaluru