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Operational Support Officers, GMP Manufacturing

Employer
Oxford BioMedica (UK) Limited
Location
Oxford
Salary
Competitive
Start date
8 Feb 2021
Closing date
8 Mar 2021

View more

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

Job Details

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

 Oxford Biomedica’s Manufacturing Team is responsible for the production and aseptic fill and finish of vectors and vaccines, for our clients and partners, to GMP standard.

We are looking for talented GMP production professionals to work as Operational Support Officers to plan and schedule core manufacturing operations to ensure compliance and operational efficiency.

Your responsibilities in this role would be:

  • The generation and maintenance of a detailed weekly production schedule derived from the master production schedule, accounting for operational challenges
  • Maintenance of cleaning schedules and BMR and label requests
  • Coordinating delivery of parts to expedite flow of materials to meet production schedule
  • Generation and maintenance of IFS product structures
  • Utilising ERP system to auto‐generate manufacturing work orders
  • Coordinating between warehouse supply chain and  manufacturing on material shortages including the implementation of appropriate change controls to introduce new or replacement materials
  • Reviewing documentation generated during manufacturing processes and for ancillary areas of manufacturing, co-ordinating of review and any follow-up actions/corrections of GMP documentation.
  • Advising operators on best practises for document completion, review and follow up actions or escalate if required
  • Assist in the capture of GMP data for the incorporation into Continuous Process Verification tables
  • Coordinating with engineering for repair and return of process critical equipment
  • Coordination of introduction of new equipment and maintenance of manufacturing equipment files
  • Coordination with engineering and validation for scheduling of validation, calibration and maintenance activities.

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

  • Higher National Certificate or Degree in Science discipline or relevant experience
  • Significant working knowledge of GMP manufacturing activities ideally across differing functions
  • Knowledge of planning/materials management systems (Computerised ERP or manual) in GMP.
  • Adept in establishing and routine use of scheduling tools.
  • Skills and knowledge in requirements for GMP compliance
  • Understanding and experience of Change Controls
  • Understanding & experience of Good Documentation Practice and Data Integrity (ALCOA+)
  • Experience in document control or records management systems in a regulated environment
  • Proven organisational & problem solving skills

Collaborate. Contribute. Change lives

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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