job description
Join Biocon, a global leader in biopharmaceutical innovation, as an Associate in Drug Substance Manufacturing in the vibrant and growing biotech hub of Bali, Indonesia. This is a unique opportunity to be part of a cutting-edge team dedicated to manufacturing high-quality biopharmaceutical products while adhering to cGMP (Current Good Manufacturing Practices), regulatory requirements, and EHS (Environmental, Health, and Safety) standards.
In this role, you will play a critical part in ensuring the seamless production of drug substances that meet global quality and safety standards. You will collaborate with cross-functional teams, including Quality Assurance, Production, and Regulatory Affairs, to drive operational excellence and compliance. Bali’s strategic location and Biocon’s commitment to innovation make this an exciting opportunity for professionals looking to advance their careers in biopharmaceutical manufacturing.
As a key member of our team, you will contribute to the production of life-saving therapies while working in a dynamic and supportive environment. Biocon offers competitive compensation, professional development opportunities, and a chance to make a meaningful impact in the healthcare industry. If you are passionate about biopharmaceutical manufacturing and eager to grow in a global organization, we invite you to apply!
Note: This role is based in Bali, with potential opportunities for hybrid work arrangements depending on business needs.
Responsibility
- Execute manufacturing operations for drug substances in compliance with cGMP, SOPs (Standard Operating Procedures), and regulatory guidelines.
- Operate and maintain biopharmaceutical production equipment, ensuring optimal performance and adherence to safety protocols.
- Monitor and document production processes, including batch records, deviations, and corrective actions, to ensure data integrity and compliance.
- Collaborate with Quality Assurance and Regulatory teams to support inspections, audits, and compliance activities.
- Identify opportunities for process improvements and contribute to continuous enhancement initiatives in manufacturing operations.
- Adhere to EHS (Environmental, Health, and Safety) standards to maintain a safe and sustainable work environment.
- Assist in training and mentoring junior team members to foster a culture of excellence and compliance.
- Support troubleshooting and resolution of manufacturing issues to minimize downtime and ensure product quality.
Qualifications
- Bachelor’s degree in Biotechnology, Biochemistry, Chemical Engineering, Pharmacy, or a related field.
- Minimum of 2 years of experience in biopharmaceutical manufacturing, drug substance production, or a related role.
- Strong understanding of cGMP, GLP (Good Laboratory Practices), and regulatory requirements (e.g., FDA, EMA, or other global standards).
- Hands-on experience with biopharmaceutical manufacturing equipment and processes, such as fermentation, purification, or fill-finish operations.
- Familiarity with EHS standards and commitment to maintaining a safe work environment.
- Excellent attention to detail and ability to maintain accurate documentation in compliance with regulatory requirements.
- Strong problem-solving skills and ability to work effectively in a team-oriented environment.
- Proficiency in English (written and verbal) is required; additional languages are a plus.