Executive - BBM

Enzene Biosciences Ltd; Pune District; On-site; INR 350,000 - 550,000; Full time

Job summary

A leading biopharmaceutical company is seeking a candidate to execute upstream manufacturing activities, emphasizing cGMP compliance. Responsibilities include operating equipment like fermenters and mixers, managing media preparations, and ensuring quality through proper documentation. Candidates should have experience in e.coli production processes, possess strong teamwork capabilities, and demonstrate interpersonal skills to work effectively across teams. This role offers an opportunity to be part of a dynamic and quality-focused environment in Pune, India.

Qualifications

• Experience working in a cGMP environment is essential.
• Hands-on experience with SS fermenters is required.
• Strong interpersonal skills needed for cross-functional collaboration.
• Strong interpersonal skills for cross-functional collaboration with internal and external customers.

Responsibilities

• Execute and operate upstream manufacturing batch activities.
• Manage media preparation and filtration activities.
• Monitor batch performance and documentation per SOP.
• Manage media preparation and filtration activities
• Maintaining Quality Management Systems related documentation like deviations, change controls, risk assessment documents etc.
• Monitoring of batch performance and data
• Hands-on experience with SS fermenters
• Experience in the equipment qualification and validations
• Proper documentation of batches as per SOP and written procedures

Skills

cGMP experience

Teamwork

Interpersonal skills

Biopharmaceutical production processes

Job description

Technical Responsibilities

• Execute and operate upstream manufacturing batch activities
• Operate process equipment like fermenter, centrifuge, homogenizer, mixers, autoclave, etc.
• Manage vial thaw, cell counting and other seed expansion activities
• Manage media preparation and filtration activities
• Maintaining Quality Management Systems related documentation like deviations, change controls, risk assessment documents etc.
• Monitoring of batch performance and data
• Hands-on experience with SS fermenters
• Experience in the equipment qualification and validations
• Proper documentation of batches as per SOP and written procedures

GMP compliance

• Apply Good Manufacturing Principles in all areas of responsibility
• Follow environment, health, and safety (EHS) requirements in the workplace
• Ensuring compliance to cGMP in area as defined by SOPs

Skills Required

• Working in a cGMP environment.
• Experience in e.coli based biopharmaceutical production processes
• Capability to work in a team and ability to handle demonstrate a good team spirit
• Strong interpersonal skills are required with the ability to work cross-functionally with internal and external customers