Senior Associate & Assistant Manager - Drug Substance Upstream

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, an innovation led global biopharmaceuticals company. Biocon Biologics is engaged in developing high quality, affordable biosimilars that can expand access to a cutting-edge class of therapies to patients globally. It is uniquely positioned as a fully integrated pure play biosimilars organization in the world and aspires to transform patient lives through innovative and inclusive healthcare solutions. The Company has a large portfolio of biosimilars under global clinical development with three of these commercialized in at least one of the developed markets of EU, U.S. and Japan. Biocon Biologics has a product pipeline of 28 molecules, including 11 with Mylan, several with Sandoz and is developing many independently. Biocon Biologics believes that strong partnerships offer enormous opportunities to co-create the future of healthcare, building a patient ecosystem beyond the product, which can transform millions of lives.

https://www.bioconbiologics.com

Roles and Responsibilities

1. To execute the process operations and monitor the batch performance as per standard procedures in the plant

2.To practice and monitor the compliance with the requirements of Good Manufacturing

3. To execute the instructions relating to production operations

4. Follow the established procedures and policies of the company pertaining to EHS management system and compliance.

5. To update the BMRs and other production records at real time

6. Maintenance and utilization of raw materials as per production requirement

7. Reporting of Non-Conformities and deviation observed during the process, investigating, arriving corrective and preventive action and ensuring the implementation of the same.

8. To ensure timely maintenance of PDS Upstream premises and equipment's in co-ordination with Engineering Maintenance and Instrumentation and Automation department.

9. To follow timely and effective communication and report process and facility related issues to appropriate higher levels

10. To execute Qualification and Validation protocols as per plan

11. To participate in Commissioning and Qualification activities

12. To prepare and revise necessary documents as and when required

13. Responsible for Process order and Inventory management in SAP system.

14. Raw material planning for the batch and procurement from the warehouse, maintenance and utilization as per production requirement.

15. Managing and closure of OOS, change management and deviation.

16. Data owner for process equipment used in day-to-day activity

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