About the role
AI summarisedSupport the setup of end-to-end production operations within a future manufacturing facility, adhering to cGMP and safety requirements. This role involves hands-on involvement in manufacturing activities, process optimization, quality compliance, and technical documentation.
BiopharmaOnsiteManufacturing
Key Responsibilities
- Support the setup of end-to-end production operations, including media/buffer preparation and manufacturing of intermediates/drug substance.
- Adhere strictly to cGMP and safety requirements throughout all manufacturing activities.
- Design and draft essential operational documents such as SOPs, Checklists, OJT guides, and WRA.
- Serve as a technical resource by providing guidance and leadership to ensure reliable process completion (for Senior Biotechnologists).
- Comply with all IOQ, commissioning protocols, SOPs, and batch record requirements while maintaining a high-quality mindset.
- Participate in deviation investigations and the implementation of Corrective and Preventive Actions (CAPA).
- Maintain clear communication with cross-functional teams (QA, QC, TS) to ensure smooth operations and timely material supply.
- Lead or contribute to the design/drafting of working instructions and SOPs to enhance GDP compliance.
Requirements
- Diploma or higher in Biotechnology, Chemical Engineering, Life Science, or a relevant field.
- Basic knowledge of cGMP is required.
- Strong documentation skills and attention to detail are essential.
- Good communication and interpersonal skills.
- Disciplined work ethic with a strong quality mindset.
- Basic IT proficiency (MS Word, MS Excel, MS PowerPoint).