Biovac Institute, The

The Biologicals and Vaccines Institute of Southern Africa (Pty) Ltd
Production Department
Bioprocess / API Manufacturing Specialists: X 1 Conjugation Specialist

Responsibilities include:
• To ensure that the manufacture of API’s and related products are carried out according to an agreed plan and according to the process as established for that particular product;
• Development of API, media and solution processes / recipe’s;
• Assist in the preparation and review of API production batch books and Standard Operating Procedures;
• Process transfer and scale-up of clinical grade production strategies to manufacture and to ensure that appropriate in process controls and testing are implemented to ensure validation of the manufacturing process (Technology transfer);
• To be part of the validation / qualification team to validate / qualify the manufacturing process under current Good Manufacturing Practices conditions;
• Collect and compile data for the preparation of technical reports especially during the technology transfer process;
• Set up, commission and qualify process equipment;
• Provide technical support to resolve process related issues;
• Involved in projects within the API manufacturing discipline and use professional concepts to solve problems in creative ways.

• B.Sc (Hons) in Biochemical/chemical or Bioprocess/process engineering, Chemistry, biochemistry, biotechnology or a similar field. M.Sc will be advantageous.
• Working experience in the production of biological Active Pharmaceutical Ingredients (API) would be advantageous.
• Working experience in biotechnology lab environment would be an advantage.
• Knowledge of fermentation, downstream processing and purification of associated proteins.
• Knowledge and understanding of aseptic processing techniques would be an advantage.
• Knowledge and understanding of biosafety regulations.
• Knowledge of cGMP and or GLP would be an advantage.

Interested persons to kindly submit their CV’s on the website www.biovac.co.za by close of business 31 October 2009.