JOB DESCRIPTION
Department: Analytical Development/CMC
Reports to: Group Leader – Analytical Development
Direct Reports: N/A
MAIN PURPOSE OF JOB
We are seeking an ambitious, highly motivated and experienced Analytical Development Scientist to join our team. This is a role where you will be able to apply your experience in a cutting-edge environment working for a growing company in an innovative environment. This is an exciting opportunity for a talented scientist to take a leading role in the development of assays for analysis of novel viral vector 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 an individual who is a self-starter, will thrive in a start-up environment, be able to coach and motivate, be able to innovate 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 Analytical Development.
KEY ACCOUNTABILITIES
- Develop and optimise analytical assays for the measurement of quality attributes and characterisation of novel viral vector products, suitable for validation within cGMP laboratories
- Ensuring method readiness by implementation of pre-qualification protocols
- Support technical transfer and validation within cGMP facilities
- To produce high quality product and platform specific analytical method documentation, such as SOPs, protocols and reports to support regulatory filings
- Ensure that all experimental and analytical data are documented following data integrity principles
- Work collaboratively with Research, Process Development and CDMOs/CROs to develop and establish new techniques and recommend alternative approaches and potential solutions to analytical issues
- Ensure a healthy and safe working environment and compliance to GMO/ACDP requirements
PERSON SPECIFICATION
Education and Qualifications:
- PhD or BSc/MSc in Chemistry, Biochemistry, Biotechnology, Food Science, Biological or Chemical Engineering or a related field.
A highly motivated and 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
- PhD with relevant industrial laboratory experience in analysis of viral vector products, e.g., AAV, LVV or AV process development or BSc/MSc with 3-4 years direct industrial laboratory experience as above.
- Proven industry experience in developing, transferring, qualifying and validating analytical methods for the measurement of viral particle titres/vector genome quantitation, genetic sequence integrity (qPCR/ddPCR) and vector loading within a regulated environment
- Experienced in the development, transfer, qualification and validation of assays for determination of capsid quantitation, purity, loading and integrity by a range of methods including UV, CE and UHPLC
- Experience in development of cell-based potency assays for viral vector products is ideal
- In-depth knowledge and extensive 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.