Skip to main content

This job has expired

Validation Manager

Employer
Oxford BioMedica (UK) Limited
Location
Oxford
Salary
Competitive
Start date
1 Oct 2019
Closing date
29 Oct 2019

View more

Discipline
Manufacturing, Validation
Hours
Full Time
Contract Type
Permanent
Experience Level
Management

Job Details

Be Inspiring and lead a team of Specialists

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

As a result of our success we are increasing our manufacturing and development capabilities which include the addition of new sites, equipment, IT systems and processes.   We therefore are able to offer the opportunity to a talented people manager to help shape our Validation function and its people.

You will be:

  • Identifying and maintaining the validation schedule to keep all manufacturing and laboratory facilities, equipment/systems, utilities and processes in a qualified state to support GxP requirements
  • Managing a team of permanent and contract Validation Specialists and resources to ensure preparation and execution of validation protocols (equipment, computerised systems and processes) to support on-going business activities
  • Responsible for the regulatory compliance of all validation activities
  • Representing the business in customer audits and regulatory inspections as a Validation Subject Matter Expert
  • Directing, instructing and supervising OEM vendors and validation service providers as required when external support is utilised for qualification activities
  • Creating / reviewing / maintaining qualification related records, procedures, documents and drawings
  • Ensuring compliance with safety, health and environmental (SHE) legislation
  • Engaging with project teams to identify resource requirements to support scheduled activities

You will need:

  • Bachelor’s degree in a relevant scientific, engineering or related discipline
  • Demonstrated understanding of validation requirements for international markets including (but not limited to) the US FDA and EMA
  • Knowledge of regulatory/GMP requirements for the qualification/validation of bulk biologics substance, finished product manufacturing and laboratory operations
  • Significant validation experience within a GxP environment; experience of new manufacturing/analytical technologies and capital projects would be an advantage
  • Demonstrable experience of managing a Team in a pharmaceutical, medical device, consumer healthcare or related industry
  • Proven problem solving skills/diagnosing faults/resolving qualification issues

 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

Get job alerts

Create a job alert and receive personalised job recommendations straight to your inbox.

Create alert