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Process Analyst, MSAT

Employer
Oxford BioMedica (UK) Limited
Location
Oxford
Salary
Competitive
Start date
19 Apr 2021
Closing date
17 May 2021

View more

Discipline
Data Management / Statistics
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

Do you want to develop your career in exciting new medical technologies? We deliver life-changing gene therapies to patients, and so can you.

Oxford Biomedica’s Manufacturing, Science and Technology Team is responsible for process and technology development activities from early concept through to product registration for market approval, to ensure that OXB’s new and existing manufacturing processes can deliver the productivity, performance, quality and cost benefits required in line with regulatory guidance.

We are currently recruiting for a talented Process Analyst to join the team.  One of the main purposes of this role is the routine (and where required non-routine) analysis of data generated during manufacturing and testing of Oxford Biomedica (OXB) manufactured products across the product lifecycle.

Your responsibilities in this role would be:

  • Collation and statistical analysis of manufacturing and analytical data to monitor process performance and capability of clinical and commercial product(s).
  • Regularly monitoring of quantitative data using statistical software; including critical and key process parameter and quality attributes, in-process controls, yields and process step cycle times as appropriate to identify improvement areas.
  • Present and report data at meetings including the Manufacturing Robustness Review Board (MRRB) Meeting.
  • To use captured process data and statistical analysis of OXB-manufactured product process performance and capability to evaluate the state of control of manufacture, to re-evaluate the suitability of quality limits and to identify possible improvement areas to reduce process variability.
  • To collate all related events that could impact process performance including changes in material lot numbers or supplier, deviations, change controls, process excursions to identify and/or justify any trends or shifts in manufacturing and analytical data.
  • Support root cause investigations into process excursions [Out-of-Specification (OOS), Out-of-Expectation (OOE) and Out-of-Trend (OOT)].
  • To prepare regular reports on process performance and capability for internal and strategic partner queries which  the Continuous Process Verification and Annual Product Quality Review (APQR) reporting.  

 To be successful in this role, you will have the following skills and experience:

  • Life Sciences Degree, Biotechnology, Chemical engineering or related discipline preferred.
  • Proven competency in the use of statistics and statistical software through direct experience or academic qualification.
  • Previous biological/chemical manufacturing experience in a GMP regulated environment would be an advantage.
  • An interest in operational excellence and continuous process improvement is desirable.

Do you want to feel inspired every day? We’re future-focused and our business is growing rapidly. We succeed together through passion, commitment and team work, and so can you.

Collaborate. Contribute. Change lives

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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