Job Description

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

Skills Required