The Key Performance Areas for this position include team leadership, technical delivery, and commercial mind-set.
- The Senior Scientist will be responsible for the overall team leadership of the Upstream Bacterial fermentation platform.
- Lead Upstream bioprocess and fermentation product development, optimisation and technology transfer activities.
- Develop novel upstream bioprocess and fermentation technologies with the potential for patent registration,publication and commercial value.
- Lead Upstream development activities by:
- Defining experimental plans and operational approaches,
- Ensuring process data is well defined, accurate, reproducible, and within defined timelines and budgets.
- Compilation of cGMP and GDocP quality documents.
- Coordinate equipment installation, commissioning, performance and operator training.
- Lead cross-departmental delivery as well as delivery to external parties.
- Ensure compliance with respect to company safety and biosafety regulations and policies.
- Lead and support a high performance and innovative team culture.
- Build multi-disciplinary synergies across teams.
- Adherence to current regulations and guidelines - both local (Medicines and Related substances Act 101 of 1965, Pharmacy Act 53 of 1974) and international.
Candidate specifications:
- A PhD or MSc with at least 3 years’ experience in the relevant discipline.
- Advanced knowledge in the principles of microbiology, fermentation, optimization and process scaleup.
- Ability to lead the planning, design and execution of; Strain development and isolate & clonal selection strategies.
- Fermentation (lab and pilot scale) experiments.
- Ability to work under biosafety level 3 containment.
- Strong skills in data analysis and statistics.
- Good presentation and technical writing skills.
- Sound leadership capability within multi-disciplinary teams
- Good decision-making skills.
- Ability to communicate and relate well with people at all levels.
- Self-starter, hands-on approach, with a drive for excellence and high standards.
- Ability to effectively prioritize multiple tasks and responsibilities.
The following would be advantageous
- Experience in cGMP Seed/ cell bank management.
- Knowledge of cGMP (SA, PIC/S, WHO) and GLP guidelines.
- Skills in QbD and DoE.
- Good publication track record.
Other requirements:
- Local and international travel may be required.
- Own, reliable transport required for possible standby and shift work.
- Flexible working hours.