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 Senior 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 and proactive scientist to take a leading role in the development of novel, state-of-the-art analytical methods for batch release, stability assessment and characterisation of exosome-based biotherapeutic products, ensuring method readiness for transfer to cGMP facilities. We are looking for an individual with experience in the development, optimisation, and oversight of a variety of Immunoassay methods for analysis and characterisation of complex biologics. The CMC AD team also supports, as required, CMC analytical testing, batch release activities and analytical method transfer to cGMP contract manufacturing organisations. The role will include the maintenance of the analytical equipment, and development of strategy for best use of this technology in the future.
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.
- Lead development and optimisation of Immunoassays for the detection, quantitation and characterisation of complex biological and quality attributes of these products. measurement of quality attributes and characterisation of complex biologics
- Become the Subject Matter Expert for Immunoassays, ensuring appropriate equipment use and maintenance defined within SOPs, and training out to other users
- Ensuring method readiness by implementation of pre-qualification protocols
- Support technical transfer and validation within cGMP facilities
- 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
- Provide technical guidance, training and coaching to other members of the Analytical Development team
- Ensure a healthy and safe working environment and compliance to GMO/ACDP requirements
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 as technical expert for respective area
- 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 some relevant industrial laboratory experience in analysis of complex biological molecules or BSc/MSc, who must have direct industrial laboratory experience as above
- Proven industry experience in developing, transferring, qualifying, and validating Immunoassay methods for biologic drug products
- Experience in flow cytometry and imaging methodologies is also desired
- Sound understanding of regulatory agency guidance associated with analytical methods and assay qualification/validation
- Experience in the application DoE to optimise analytical assays would be an advantage
- Additional assay development experience in other biological assays such as qPCR, cell-based assays, potency methods (including bioassays) and Ultra-Centrifugations is a benefit
- 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.