Scientist – Viral Vector Product Downstream Process Development

JOB DESCRIPTION

Department: Process Development/CMC                                          

Reports to: Group Leader - DSP

Direct Reports: N/A                                     

MAIN PURPOSE OF JOB                                                                                                                         

We are seeking an ambitious and highly motivated downstream process development (DSP) Scientist to be involved in all aspects of DSP process development for viral vector products. This is an exciting opportunity for a talented scientist to contribute to the development of de novo processes for novel viral vector products. The CMC DSP team also transfers and supports, as required, developed processes internally to CMC-Manufacturing and externally to cGMP contract manufacturing organisations.

We are looking for an individual who will thrive in a start-up environment and relish the sense of accomplishment each day brings in our exciting company.

This position is based at Evox Therapeutics facility at the Oxford Science Park, Oxford, UK and reports to the Group Leader, Downstream Process Development

KEY ACCOUNTABILITIES

• Contribute to the development, optimisation, and establishment of robust, scalable and industry leading DSP processes to produce high quality viral vector products, meeting the requirements for quality and recovery/yield.
• Provide scientific and technical support to assist the transfer and establishment of into CMC-Manufacturing or cGMP - for example process risk assessments, technology transfer documentation and scale-up assessments.
• Contribute to the resolution of technical and scientific issues that affect, or have the potential to affect, the development and execution of downstream processes for the manufacture of biologics.
• Deliver product specific and platform DSP documentation, process flow diagrams and reports ensuring appropriate quality of documentation to support inclusion of data and information in regulatory filings.
• Work collaboratively with Research, Cell Line Development, Upstream Process Development, Analytical Development, CMC-Manufacturing and Quality to develop and establish new techniques and recommend alternative approaches and potential solutions to downstream processing issues.
• Ensure a healthy and safe working environment and compliance to GMO/ACDP requirements.

PERSON SPECIFICATION

Education and Qualifications:

• BSc/MSc in Cell Biology, Biochemistry, Biotechnology, Food Science, Biological Sciences, Biochemical Engineering, or a related field.

A highly motivated ambitious scientist with:

• Ability to work independently.
• Good conceptual, analytical thinking, problem solving, and organisational skills.
• Ability to work in a high paced team environment, meet deadlines, and prioritise work from multiple projects.
• Strong interpersonal and communication skills with demonstrated ability to work within a team environment.
• Ability to balance multiple priorities and projects at the same time and be able to change priorities as needed by the business.

 

Experience & knowledge


 

 

• Demonstrable relevant industrial laboratory experience in downstream process development for biological products.
• Experience in downstream process development/purification of viral vector products, from cell culture harvesting through to drug substance/purified product. This would preferably have been gained working with viral vectors such as LVV, AAV or AV.
• Experience with chromatography systems such as Akta Purifier/Pure/Avant and a good understanding of chromatography techniques e.g., IEX/SEC/HIC/Affinity. Experience and understanding of tangential flow filtration are also desirable.
• Experience of routine analytical techniques such as SDS-PAGE, Western Blotting and biochemical assays is desirable.
• Experience in the application DoE.

KEY BEHAVIOURAL ATTRIBUTES – ALL STAFF


 

People with Purpose – We are innovative and creative in the way we work and deliver. We treat each other with respect and dignity and work collaboratively to learn from each other’s strengths.

 

Driven to Deliver – We strive to deliver our objectives, and then look for our next challenge. We recognise our achievements and celebrate our successes.

 

Agile and Accountable – We respond to challenges impacting our progress and find creative and innovative solutions to overcome obstacles. We are brave and not afraid to change our approach to achieve a positive outcome in optimum time.

 

Candid and Constructive – We communicate with honesty and transparency throughout the team.  We value giving and receiving constructive feedback to each other and our partners.