Description
The Biotechnologist / Senior Biotechnologist will support the set-up of end-to-end production operations within the manufacturing facility to achieve productivity targets and objectives in a reliable, efficient, and cost-effective manner, meeting Quality and Health, Safety and Environment (HSE) regulations and other regulatory standards.
Key Responsibilities
- Operations: Support the set-up of production operations, including preparation and supply of media, buffers, and materials, and manufacturing of intermediates and drug substance.
- Optimization: Optimize utilization of capacity and manufacturing resources with sustained efficiency.
- Quality: Adhere to cGMP and safety requirements, participate in commissioning and qualification activities, and ensure compliance with regulatory requirements.
- Planning and Scheduling: Adhere to project timelines, assist in detailed team operations planning, and ensure smooth operations.
- Training and Development: Ensure training and qualification in SOPs and OJTs, provide guidance and support to new joiners, and develop oneself as a process SME.
- Quality: Comply with IOQ, commissioning protocol, SOP, and batch record requirements, perform timely review of documentation, and participate in deviation investigation and CAPA.
- Reporting and Documentation: Operate key computer applications, maintain clear communication with colleagues, and participate in development and generation of production checklists, SOPs, and validation protocols.
- Technology Transfer: Participate in new technology and process transfers.
- Security, Safety, and Environment: Adhere to site safety procedures, ensure safe operations, identify and report potential safety issues, and participate in safety inspections and risk assessments.
- Interface with Other Departments: Coordinate with department colleagues to ensure timely supplies of materials and buffers, calibration and maintenance activities, and open communication on sampling requirements.
Knowledge, Skills, and Experience
- Nitec/Higher Nitec/Diploma in Biotechnology/Chemical Engineering/Life Science or relevant field.
- Experience in biologics, chemical, pharmaceutical, or food industry preferred.
- Good communication, documentation, and IT skills.
- Basic knowledge of cGMP.
- Specific skills for different roles: fermentation, purification, material prep, and media/buffer preparation.