- Essential: BSc Honours in Cell Biology, Biochemistry or Biotechnology
- Preferred: MSc degree in Cell Biology, Biochemistry or Biotechnology
- 2-3 years cell / tissue culture experience and monoclonal antibody generation, other general tissue culture techniques and ELISA
- Understanding of ISO 13485:2016
- Familiar with SAP
Specific Operational Requirements
- The successful candidate will be required to work an 8 hour day between 08h00 to 16h00
- The successful candidate may be required to work overtime to meet the business needs
In line with the Employment Equity Act, preference will be given to those applicants whose appointment will address the demographic imbalances in our work force profile.
Due to the nature of the business, pre-employment, routine and exit medical examinations are compulsory.
- All personal information received will be processed in accordance with The Protection of Personal Information Act No. 4 OF 2013
Applications are invited from suitably qualified candidates meeting the minimum requirements. To apply for this position, please click here https://nbi-sa.jonti2.co.za/.
If you have not had a response from us within 30 days after the closing date, kindly accept that your application has been unsuccessful
Key Performance Areas
Plans, organises, co-ordinates and executes production activities of the Hybridoma laboratory
- Develops and produces specific Hybridoma-producing monoclonal antibodies for research, diagnostic and commercial purposes
- Explores and develops ideas with reference to all aspects of monoclonal antibody production and cell culturing, evaluating proposals, implementing experiments and interpreting and reporting results.
- Maintaining an onsite and offsite cryogenic repository of Hybridoma clones that produce saleable mAbs.
- Culture the appropriate Hybridoma cell line for the agreed time period to meet the projected sales forecast.
- Participates in assay troubleshooting discussions and efforts.
- Compiling work instructions and standard operating procedures.
- Ensure adherence to work instructions and documenting work through production records and on SAP DMS.
- Use SAP for recording and processing process steps.
- Control of virological and microbial contamination through practicing aseptic techniques and regular monitoring of microbial growth in the laboratory environment.
- Keep abreast of industry developments in Hybridoma technology and provide feedback to the group at the appropriate forum.
- Apply industry knowledge to keep NBIs Hybridoma production processes in line with industry practices and technical and scientific developments.
- Training and supervision
- Supervise Hybridoma laboratory staff
- Develop a training schedule and development plan for the Hybridoma laboratory staff in accordance with outlined training requirements on Skillogics competency framework.
- Manage day to day tasks and performance of laboratory staff
- Compile annual Hybridoma Laboratory Budget for consumables; reagents and equipment.
- Assist with the drafting of User Requirement Specifications for new laboratory equipment.
- Assist with the qualification of new equipment in line with NBIs Quality Management System.
- Ensure adequate laboratory supplies for daily operations.
- Conduct stock taking as per supply chain schedule
- Ensure equipment functionality through regular service and validation.
- Thoroughly analyse and summarize process and operational performance data for monthly and quarterly reporting and presentation at Management Review meetings.
- Adhere to NBIs Quality Management System requirements in the Laboratory.
- Ensure ISO13485:2016 requirements are met in the laboratory.
- Document management on SAP DMS
- Document process changes and non-conformances using the SAP notification system.
- Prepare for and participate in internal and external audits of the Hybridoma laboratory.
- Address all internal and external audit findings and close off CAPAs timeously within specified calendar days.
- Ensure continuous improvement by using a risk-based approach to address CAPAs and conduct staff training in compliance with ISO 13485:2016 and ISO 14971:2019 standards.
- Technical knowledge and skills
- Decision making
- Project Management
- Management Work
- Initiating work
- Ability to work independently, multitask and meet deadlines.
- Excellent verbal and written communication skills