Scientist - Bioprocessing Downstream

**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 Bioprocessing Technology Institute (BTI) and the Company. As a Scientist (Downstream Process Development) you will work on a number of novel activities within Process Development on a new method of AAV manufacture called TESSA technology. Downstream process development involves a range of internal platform development activities, primarily focusing on improving and expanding capabilities for AAV vector concentration and purification processes. You will work on the implementation of new processes and technologies for scalable downstream processing of viral vector produced from 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.

You will work closely with other viral vector groups within the company in the USA, UK and China and also work closely with the upstream and analytics teams within BTI. The role will report to the group leader for this newly formed group.

**KEY RESPONSIBILITIES:
- Planning and conducting primary purification experiments as well as designing scale up/down and optimisation experiments that may include the use supporting statistical analysis for process design and optimisation (DOE, QbD).
- Support process development, scale up and optimisation activities for development of internal platforms and commercial projects
- Working closely with internal and external stakeholders including project managers and external customers, to define project goals and deliverables, in line with planned project and company objectives and to meet sometimes ambitious timelines
- 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/ chemistry discipline or MSc/BSc in relevant discipline with significant work experience within industry (2-5 years)
- Experience working with chromatography (AKTA systems or equivalent) and TFF systems for processing and purification of biologics, ideally viral vectors.
- Able to take responsibility for an experimental workflow and to coordinate staff and resources to facilitate project progression within the group.
- Well-developed written and verbal skills, including the ability to prepare written reports, give presentations and to speak to groups
- Team player and good communication skills
- Ability to work under demanding conditions, and to cope with shifting priorities while maintaining high level attention to detail

**DESIRABLE CRITERIA:
- Understanding of biological systems, biochemical molecule interactions and biopharmaceutical production, preferably based on viral vector production. Upstream and analytical experience and/or knowledge would be an advantage
- Direct experience in handling viral vectors recovery and purification (Lentivirus, AAV and/or Adenovirus)
- Ability to carry out research to broad targets and with limited supervision
- Awareness of commercial implications of research
- Advanced computing and/or data analysis skills (e.g. Design of Experiments, R, Advanced MS Excel skills, comparative statistics)
- Experience working in a biopharmaceutical research or manufacturing environment, Understanding of GMP regulations and QbD principles and guidelines for process development
- Experience working within controlled quality management system (e.g. ISO 9001, GxP)
- Experience working with ELN and LIMS systems