11/01/2022
Description:
Responsible for planning Mammalian Cell Culture/Microbial Manufacturing suite running upstream / downstream processes in support of clinical and commercial protein manufacturing of biosimilar products, in order to meet quality parameters, productivity and efficiency goals.
Requirements:
Graduate with 2 To 9 years extensive experience with area-relevant processes and technology
Experience with Quality Systems such as Deviation, CAPA, Change Control Systems required
Experience in troubleshooting, investigation, root cause and risk analysis in a CGMP environment required.
Excellent communication skills, good presentation skills
Duties and Responsibilities:
Commercial and clinical manufacturing of Biosimilar mAbs and therapeutic proteins.
Technology transfer and Scale-up for Cell Culture and Purification
Facility Management including inspections and audits
Ensures the safety of work practices
Ensures that all production activities are in compliance with CGMPs
Ensures staff is sufficiently trained to perform their job responsibilities
Provides technical subject matter expertise for the area
Oversees, either directly or indirectly, investigations and process deviations
Carrying out activities related to Occupational Health, Safety and Environment Management as per SOP
Awareness/Knowledge on the consequences of not following Standard Operating Procedures related to Occupational Health, Safety and Environment Management
Location : Navi Mumbai
https://www.flysquaresolution.com/careers/jobs/2-9-years-experienced-mammalian-cell-culture-microbial-profiles-for-biosmilars-manufacturing-navi-mumbai/
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