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JOB DESCRIPTION

 

Department: Quality                                   

Reports to: Director- Quality

Direct Reports: 6-8                                       

 

MAIN PURPOSE OF JOB                                                                                                                         

We are seeking a highly motivated and experienced Quality Control (QC) scientist to join our Quality organisation. You will build and lead our newly created QC group to deliver exosome product-specific QC testing, method transfer and qualification, highest compliance to QC data integrity and laboratory/sample management. You will coordinate with the QC and Quality functions of partner Contract Development and Manufacturing Organisations (CDMO’s) to deliver GMP testing responsibilities that are split between Evox QC and the CDMO’s QC.

 

We are looking for an individual who will thrive in a start-up environment, be able to lead and motivate, be able to innovate and relish the sense of accomplishment each day brings in our exciting company.  This is an opportunity to truly establish and grow the QC function within Evox.

 

This position is based at Evox Therapeutics facility at the Oxford Science Park, Oxford, UK and reports to the Director - Quality.

 

KEY ACCOUNTABILITIES

  • Lead, grow and establish the QC group to deliver GMP compliant exosome product specific testing of drug substance, drug product, finished product, stability samples and reference standards.
  • To work collaboratively with partner CDMO Quality and QC functions to deliver the overall testing and Certificates of Analysis required for drug substance, drug product, finished product, stability samples and reference standards.
  • Work collaboratively with the analytical development groups to transfer and qualify analytical methods and where required support testing of non-clinical (research) samples.
  • Oversight of QC analytical method deployment at CRO’s and CDMO’s.
  • Deliver Certificates of Analysis ensuring timely completion, data integrity and quality of documentation.
  • Ensure a healthy and safe working environment and compliance to GMP, COSHH, GMO/ACDP requirements.

 

PERSON SPECIFICATION

Education and Qualifications:

PhD or BSc/MSc in Chemistry, Biochemistry, Biotechnology, Food Science, Biological or a related field.

A highly motivated ambitious scientist with:

  • Ability to work independently and lead others.
  • Good conceptual, analytical thinking, problem solving, and organisational skills.
  • Ability to work in a high paced team environment, focussing on compliance, meeting deadlines, and prioritising work from multiple projects.
  • Strong interpersonal and communication skills with demonstrated ability to work within both an internal team environment and the extended team (e.g. with CRO/CDMO).
  • 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 direct QC laboratory experience in pharmaceutical, biologics and/or cell/viral product QC testing following PhD or  experience gained within a direct industrial laboratory experience as above following BSc/MSc.
  • The candidate will have broad experience in biologics or cell product or cell/viral product release and characterisation methods.
  • Experience of leading a team.
  • Experience in building QC infrastructure and participation in QC facilities audits by the MHRA would be beneficial.
  • Experience in transferring, qualifying, validating methods in a regulated environment.
  • Sound understanding of regulatory agency guidance associated with control laboratory (QC) operation and compliance.


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.


Already working at Evox Therapeutics?

Let’s recruit together and find your next colleague.

email
@evoxtherapeutics.com
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