Senior Upstream Biologics Associate — Drug Substance

Biocon Biologics; Johor Bahru; On-site; MYR 120,000 - 180,000; Full time

Job summary

Biocon Biologics is a subsidiary of Biocon Ltd., a global biopharmaceutical innovator. The company focuses on high-quality biosimilars to expand access to therapies worldwide.

It operates as a fully integrated biosimilars organization with a pipeline of molecules in global development. Roles involve executing production operations, ensuring GMP compliance, maintaining records in SAP, and participating in commissioning and qualification activities.

Qualifications

• Bachelor's Degree in Biotechnology, Chemical Engineering, Bioprocess Engineering, Biochemistry or equivalent.
• 4–11 years of hands-on experience in biopharmaceutical or pharmaceutical Drug Substance manufacturing or related process operations.

Responsibilities

• Execute process operations and monitor batch performance per standard procedures.
• Ensure compliance with Good Manufacturing Practices (GMP).
• Execute instructions relating to production operations.
• Follow established procedures and policies of the company pertaining to EHS management system and compliance.
• Update the BMRs and production records in real time.
• Maintenance and utilization of raw materials as per production requirement.
• Reporting of non-conformities and deviation observed during the process, investigating, CAPA and implementation.
• Coordinate maintenance of PDS Upstream premises and equipment with Engineering Maintenance and Instrumentation and Automation.
• Follow timely communication and report process and facility related issues to higher levels.
• Execute Qualification and Validation protocols as per plan.
• Participate in Commissioning and Qualification activities.
• Prepare and revise necessary documents as and when required.
• Responsible for Process order and Inventory management in SAP system.
• Raw material planning for the batch and procurement from the warehouse, maintenance and utilization as per production requirement.
• Managing and closure of OOS, change management and deviation.
• Data owner for process equipment used in day-to-day activity.

Education

Bachelor's Degree in Biotechnology

Bachelor's Degree in Chemical Engineering

Bachelor's Degree in Bioprocess Engineering

Bachelor's Degree in Biochemistry

Job description

Biocon Biologics is a subsidiary of Biocon Ltd., a global biopharmaceutical innovator. The company focuses on high-quality biosimilars to expand access to therapies worldwide.

It operates as a fully integrated biosimilars organization with a pipeline of molecules in global development. Roles involve executing production operations, ensuring GMP compliance, maintaining records in SAP, and participating in commissioning and qualification activities.