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Senior Validation Specialist, Vector Product (Fill/Finish)

Employer
Oxford BioMedica (UK) Limited
Location
Oxford
Salary
Competitive
Start date
10 Oct 2019
Closing date
7 Nov 2019

View more

Discipline
R & D , Biotechnology
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

Oxford BioMedica is a pioneer of gene and cell therapy and our work is helping to deliver life changing treatments.

As a result of growth we are increasing our manufacturing and development capabilities which include the addition of new sites, equipment, IT systems and processes.   We are therefore able to offer opportunities to Senior Validation Specialists to join our team and focus within their field of validation expertise.

As an expert you will be:

  • Creating and maintaining validation master plans, schedules to ensure that all equipment, facilities, and utilities are maintained in a qualified state to support our fill finish (vector product) GMP requirements
  • Assisting system owners with system/equipment URS and DQ documents and uses a risk-based approach to determine the appropriate validation requirements
  • Creating, reviewing approving and executing validation plans and protocols (equipment, facilities, utilities,) to meet defined timelines
  • Generating, reviewing, executing and approving validation reports in a timely manner on completion of validation activities
  • Managing validation reviews, re-qualifications and revalidations to ensure maintenance of the ‘validated state’ and ongoing GMP compliance
  • Demonstrating and fostering a culture of continuous improvement in support of the business aims/objectives and identifies, investigates and implements efficient, effective and compliant ways of working.

To be our expert you will have:

  • A bachelor’s degree in a relevant scientific, engineering or related discipline
  • Proven experience as a validation specialist and/or senior validation specialist roles gained within GMP manufacturing/analytical environments in biopharmaceuticals or pharmaceuticals sectors preferred
  • Experience within aseptic processing and/or ‘fill & finish’ environments
  • Strong team-orientation with a proven ability to coach/mentor and lead less experienced members of the validation team in project-related activities
  • Proven ability to work in multi-project environments, identify priorities and work collaboratively, utilising effective time management skills, to deliver results within predefined timescales
  • Excellent spoken English communication and proven influencing skills at varying levels within the organisation, across functions and multiple project teams.

We look forward to receiving your application.

No agencies please.

Company

Oxford Biomedica is a quality and innovation-led viral vector CDMO that enables its clients to deliver life-changing therapies to patients around the world. One of the original pioneers in cell and gene therapy, Oxford Biomedica has more than 25 years of experience in viral vectors, the driving force behind the majority of gene therapies.  

Cell and gene therapy is the treatment of disease by the delivery of therapeutic genetic material (DNA or RNA), into a patient’s cells. One highly effective approach to delivering genetic information is to re-engineer existing viruses to be safe delivery vehicles (vectors) to insert the genetic material into patients’ cells. This can be achieved either by directly administering the vector to the patient (often referred to as in vivo gene therapy), or by first introducing the genetic material to cells or tissue outside of the body, before administering the cells or tissue into the patient (often referred to as ex vivo gene therapy or gene-modified cell therapy).  

Oxford Biomedica collaborates with some of the world's most innovative pharmaceutical and biotechnology companies, providing viral vector development and manufacturing expertise in lentivirus, adeno-associated virus (AAV) and adenoviral vectors. Oxford Biomedica's world-class capabilities span from early-stage development to commercialisation. These capabilities are supported by robust quality-assurance systems, analytical methods and depth of regulatory expertise. 

Oxford Biomedica, a FTSE4Good constituent, is headquartered in Oxford, UK. It has locations across Oxfordshire, UK and near Boston, MA, US. Learn more at www.oxb.comwww.oxbsolutions.com, and follow us on LinkedInTwitter and YouTube

Life at Oxford Biomedica

We value everyone’s unique contribution, we appreciate everyone’s individuality, and every job matters.

Your contributions are recognised and appreciated. Your work-life balance matters. We recognise, develop and use your strengths. It’s a place where you are valued as a whole person, as an individual and as part of a team.

No matter who you are, or what you do, your work will make a significant difference.

We go the extra mile, every day, because we truly care. We work together as a team to achieve our life changing therapies. Our talented colleagues help to build other people’s futures, so can you. We empower each other to be our best.

We have access to like-minded scientists and engineers, working in the latest technologies.

Our community of experts create new life-saving cures. Shaping the business’ future through collaboration. Our people are on a continuous professional development journey aided by a thought-provoking environment. A place for experts to be stretched, and future experts to be nurtured. We inspire creativity and deliver great science, and so can you.

Our supportive culture invites talent, while creating future innovators.

We’ll give you a place where you can learn, grow and contribute to the future of cell and gene therapy. We create opportunities and invest in our people, promoting ongoing learning.  Our defined career pathways provide opportunities for everyone to achieve their career potential.  We make a difference, and so can you.

Company info
Website
Telephone
+44 (0) 1865 783 000
Location
Windrush Court
Transport Way
Oxford
OX4 6LT
United Kingdom

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