Senior Scientist - Bioanalytical

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JOB DESCRIPTION

Department: Clinical and Translational Medicine & Regulatory Affairs    

Reports to: Group Leader – Immunology and Translational Analytics

Direct Reports: n/a                                    

MAIN PURPOSE OF JOB                                                

We are seeking a highly motivated and experienced Senior Scientist - Bioanalytical to join our Clinical and Translational Medicine & Regulatory Affairs department. Working within Translational Analytics, you will be an integral  member of an expanding team involved in all aspects of bioanalysis for a range of exosome platform-based programs. You will use your knowledge and experience to design, develop and validate fit-for-purpose assays to enable delivery of high-quality data to drive key project decisions, progress projects towards the clinic and to further our understanding of Evox’s platform and pipeline in rare diseases. Work will also involve conducting experiments and data analysis to characterise PK, PD and ADA responses, and as required, manage the interaction with our partner organisations.

KEY ACCOUNTABILITIES

  • Design and develop a range of bioanalytical methods suitable for use in preclinical and clinical studies across multiple exosome platform-based protein, RNA and AAV vector programs
  • Help build and shape Evox’s laboratory bioanalytical capabilities
  • Execute stage appropriate assays, analysis and interpretation of PK/PD and ADA response data, and reporting of findings
  • As required support transfer of validation-ready assays and oversee validation studies within GLP/GCLP compliant laboratories
  • As a translational bioanalytical representative, work collaboratively across functions, CROs and pipeline project teams to define and implement integrated bioanalytical plans
  • Act as point-of-contact as the subject matter expert in ligand-binding assays and immunogenicity assays
  • Keep abreast of technical advances in relevant fields
  • Evaluate, make recommendation and implement relevant new technologies
  • Contribute to solving bioanalytical challenges, provide technical guidance, training and coaching to other team members
  • Execute good documentation practice

PERSON SPECIFICATION

  • Highly motivated individual who enjoys working collaboratively across functions
  • Ability to work independently and in a high-paced team environment, setting priorities for work from multiple projects to deliver objectives
  • Organised with strong attention to detail
  • Clear written and verbal communications skills with the ability to clearly convey processes, results and key messages and able to build rapport, quickly and effectively

Experience & knowledge

  • BSc/MSc with established industry experience, or PhD with experience in bioanalysis either in industry, clinical laboratories and/or biomedical research
  • Extensive hands-on experience in the development, validation of quantitative immunoassays and immunogenicity assays, and performance of analysis using a range of technology platforms
  • In-depth knowledge of immunoassay with extensive experience of pharmacokinetic, immunogenicity (ADA) and biomarker analysis of large molecule biologics, additional experience with gene therapy and/or nucleic acid bioanalysis would be advantageous
  • Experience in transfer of validation-ready assays and oversee validation studies within GLP/GCLP compliant laboratories
  • Familiar with current regulatory guidelines and best practices for bioanalytical method development and validation for large molecule and/or gene therapies
  • Strong understanding of GLP and GCP principles, experience of working in a GxP regulatory laboratory would be advantageous  
  • Contribution to reporting of data, protocols, SOPs, regulatory documents, and internal written reports

KEY BEHAVIOURAL ATTRIBUTES – ALL STAFF

People with PurposeWe 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 DeliverWe strive to deliver our objectives, and then look for our next challenge. We recognise our achievements and celebrate our successes.

Agile and AccountableWe 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.

Or, know someone who would be a perfect fit? Let them know!

Oxford

Evox Therapeutics
OX4 4HG Oxford Directions careers@evoxtherapeutics.com +44 (0)1865 819140 View page

Benefits

  • Private Medical Cover

    Cover offered is for new and pre-existing conditions

  • Life Assurance

    Cover offered is 4 x base salary

  • Holidays

    25 days holiday plus bank holidays

  • Pension

    Employer contribution 5%, employee minimum contribution 5%, however, more than 5% can be contributed if you wish

  • Discretionary Bonus

    Bonus is payable based on a combination of corporate and personal performance

  • Evox Stock Options

    Stock Options are issued once the probationary period is passed

Workplace & Culture

At Evox, values are at the heart of how we operate, how we behave, and how we will drive the growth of our exciting company.

We developed the values internally with all our employees, ones which we could all identify and work with.


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@evoxtherapeutics.com
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