GM Bio-manufacturing (Advanced Biotech Lab)

About the role

Job Description

Job Title:	General Manager and Above
Qualification:	M.Sc./M. Tech./PhD in Biotechnology/Biochemistry
Experience:	Over 15 years
Department:	Bio-manufacturing (Advanced Biotech Lab)
Plant / Division / Sub-Dept.:	Drug Substance and Drug Product Manufacturing, QC, Engineering, Warehouse, Statutory approvals, Regulatory support/Audits and Site management
Location:	Pithampur, Indore
Role:	l Having single use manufacturing experience (Desirable) l Tech Transfer from R&D to Manufacturing , scale-up , clinical and commercial manufacturing l Quality control management l Responsible for Warehouse , Engineering and Maintenance l Responsible for Regulatory and Statutory Approvals for regulated and semi-regulated markets l Site management l Manufacturing of affordable drugs by implementing innovative solutions l Out-licensing, co-development and Manufacturing support to the collaborator l Establishment of E.coli /Microbial Pilot plant facility and mammalian GMP pilot facility l Team building and team management
Key Responsibilities:	l Process scale up and clinical manufacturing l Commercial production of mAb and Non-mAb products l Warehouse and Engineering management l Quality management l Batch planning and successful completion of manufacturing batches in line with market demand
Key Activities:	l Commissioning and Qualification of the equipment and facility l Statutory and regulatory approvals for Bio-manufacturing and product launch l Team building and Team management l Tech transfer and scale up for clinical and commercial manufacturing l Implementation of Novel platforms l Work out the first cut costing of all the products, which are planned and to be planned in line with expected cost for sale l Implementation of Automation and Paper less systems l Preparation for Audit and qualification l Implementation of Quality systems and Documentation practices as per guidelines l Site management