We are seeking an ambitious, highly motivated and experienced Analytical Development (AD) Associate to be involved in analytical method development and routine sample testing within the function of CMC Laboratories. This is an exciting opportunity for a talented individual who is interested in working with novel, state-of-the-art analytical technology for exosome-based biotherapeutic products. The CMC AD team also supports, as required, CMC analytical testing, batch release activities and analytical method transfer to cGMP contract manufacturing organisations.
We are looking for a motivated individual who is a self-starter and will thrive in a fast-pace start-up environment.
This position is based at Evox Therapeutics facility at the Oxford Science Park, Oxford, UK and reports to the Group Leader, Analytical Development.
- Develop assays for our clinical product testing, including product characterisation, potency, and stability assays
- Perform testing of in-process, final product, stability and raw material samples according to Standard Operating Procedures. Test methods include ELISA, FACS, gel electrophoresis, PCR, spectroscopy, protein assays, potency and identity tests
- Write or revise SOPs for analytical methods
- Assist with establishing procedures for QC sampling and testing
- Write and revise protocols and technical reports as necessary
- Coordinate shipment of samples to contract testing laboratories and review of testing/data reports
- Complete documentation in accordance with current Good Manufacturing Practices (cGMP).
Education and Qualifications:
Master’s degree in a scientific discipline or other related biological science or BSc (2.1 or higher) with 2 years’ of laboratory experience.
A highly motivated and ambitious individual 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
- Proven industry experience in bioassay development and proficiency in analytical methods such as cell-based assays, flow cytometry, qPCR, SDS PAGE, ELISA, and HPLC.
- Applicants with experience in exosome, nanoparticle or viral vector analytics, such as Nano flow cytometry, NTA or similar, would have a distinct advantage.
- A working knowledge and practical experience with interpretation of analytical data, good understanding of statistical methods and experience using data analysis software is required.
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.