Job Category: Biosmilars Manufacturing
Job Location: Navi Mumbai
Job Type: Full Time
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
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