Scientist - Bioprocessing Upstream

**Company Overview:
**WuXi Advanced Therapies**:

- Accelerating Progress and Time to Market
- Integrated Manufacturing and Testing Service Platform
- Solutions From Gene of Interest to Global Commercial Launch

The advanced therapies business unit of WuXi AppTec is a leading cell and gene therapy Contract Testing, Development and Manufacturing Organization (CTDMO) that is reducing the complexities of manufacturing by providing integrated platforms that enable cell and gene therapies to be developed, manufactured, and released faster and with greater predictability.

**ROLE OVERVIEW:
An exciting new role is being made available to work on AAV manufacturing approaches as part of an ongoing collaboration between Singapore Biotechnology Processing Institute and the Company. As a Scientist (Upstream Process Development) you will work on a number of novel activities within Process Development on a new method of AAV manufacture called TESSA technology. Upstream process development involves a range of internal platform development activities, primarily focusing on improving and expanding capabilities for AAV vector production processes. You will work on the implementation of new processes and technologies for scalable production of viral vector in suspension-based mammalian cell culture using the TESSA technology. The position will involve interaction with both internal and external stakeholders, and the ability to show commitment to scientific development and innovation are considered essential.

Prior experience of operating small
- and large-scale bioreactors (ambr15, DASGIP 1L, 3L, 10L or equivalent) is desirable along with experience in developing and implementing associated process for mammalian production systems. You will also work closely with other viral vector groups within the company in the USA, UK and China and also work closely with the downstream and analytics teams within the Singapore Bioprocessing Institute. The role will report to the group leader for this newly formed group.

**KEY RESPONSIBILITIES:
- Plan and conduct viral vector production in shake flasks and bioreactors ranging from 1L to 10L scale
- Support process development, scale up and optimisation activities for development of internal platforms and commercial projects
- Design and execute experiments, including translation of small-scale experiments to bioreactor scale production and use of statistical approaches to process optimisation (e.g. DoE)
- Support junior staff in their daily work and development where, and if, required. Set an example to other colleagues and provide training and mentoring
- Review and author Standard Operating Procedures for new and existing processes; ensure established quality standards for existing processes; write technical reports
- Support and contribute to protection and assessment of intellectual property, prepare publication materials (posters, presentations) with support from senior colleagues
- Ensure efficient and accurate documentation management; provide accurate records within ELN and LIMS systems
- Ensure high cleanliness standard and best practices in the laboratories and shared spaces

**ESSENTIAL CRITERIA:
- A PhD in relevant biology/biotechnology discipline or MSc/BSc in relevant discipline with significant work experience within industry (2-5 years)
- Prior experience of preparation, maintenance and operation of bioreactors up to 1-10L scale for mammalian cell culture (preferably viral vector production)
- An engineering mindset - good ability to utilise statistical approaches (in particular Design of Experiments) to optimize processes and procedures
- Understanding of bioreactor scaling parameters and experience of transitioning a process between scales
- Well-developed interpersonal, written and verbal skills, including the ability to prepare written reports, give presentations and to speak to groups
- Ability to work under demanding conditions, and to cope with shifting priorities while maintaining high level attention to detail

**DESIRABLE CRITERIA:
- Previous experience of developing suspension processes for mammalian cells
- Direct knowledge around rAAV vector manufacture
- Understanding or experience of working with high cell density, continuous, semi-continuous or perfusion processes
- Understanding of GMP regulations and QbD principles and guidelines for process development
- Ability to carry out research to broad targets and with limited supervision
- Awareness of commercial implications of research
- Experience working with ELN and LIMS systems
- Understanding of key areas of viral vector production, including downstream processing, analytics, molecular biology and virology and their interaction with upstream activities in context of gene and cell therapy products