QC Stability Officer IV

2 weeks ago

Oxford, Oxfordshire, United Kingdom Oxford BioMedica (UK) Limited Full time

Job description:

We are at the centre of the rapidly growing cell and gene therapy sector. We deliver life-changing therapies to patients, and so can you.

We are currently recruiting for a QC Stability Officer IV to join the Analytical Development and Quality Control (ADQC) Team. The purpose of this role is to ensure timely reporting of stability data, manage the client stability programs at OXB and advise our clients on various stability requirements in-line with regulatory guidelines.

Our AD&QC team supports the development of products through analytical testing to facilitate manufacturing, shelf life setting and process development, ensuring appropriate quality controls and use of analytics. The QC Stability Officer role is office based.

Your responsibilities in this role would be:

  • Generate, SME review and issue stability plans, protocols, and reports in a timely manner.
  • Perform data integrity checks and trend analysis for stability data.
  • Effective communication with clients, Contract Testing Organisations. (CTO) and internal teams to set up new stability studies and manage existing ones.
  • Attend internal and external team meetings to answer any stability related questions.
  • Support the group in Client audits and regulatory agency inspections.
  • Raise and progress Quality Records (e.g. Deviations, Investigations (OOT, OOE), Change Controls, CAPAs) within a timely manner.
  • Maintain and update stability scheduling tools in a timely manner.
  • Work both independently and alongside members of OXB.

We are looking for:

  • Educated to degree level within Life Sciences.
  • Proven experience working within a pharmaceutical regulated environment.
  • Proven experience within a GMP & QC testing environment.
  • Working knowledge of stability testing and stability regulatory guidelines
  • Experience working with Quality Management Systems.
  • Thinking critically and analytically in order to problem solve.
  • Computer literate (word, excel, MS Office).
  • Highly organised and motivated with excellent attention to detail.
  • Proven client facing experience.

About Us:

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

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

What's in it for you:

  • Highly competitive total reward packages
  • Wellbeing programmes
  • Development opportunities
  • Welcoming, friendly, supportive colleagues
  • A diverse and inclusive working environment
  • Our values are: Deliver Innovation, Be Inspiring and Have Integrity
  • State of the art laboratory and manufacturing facilities

We want you to feel inspired every day. We're future-focused and our business is growing rapidly. We succeed together through passion, commitment, and teamwork, and so can you.

Collaborate. Contribute. Change lives.

Profile description:

We are looking for:

  • Educated to degree level within Life Sciences.
  • Proven experience working within a pharmaceutical regulated environment.
  • Proven experience within a GMP & QC testing environment.
  • Working knowledge of stability testing and stability regulatory guidelines
  • Experience working with Quality Management Systems.
  • Thinking critically and analytically in order to problem solve.
  • Computer literate (word, excel, MS Office).
  • Highly organised and motivated with excellent attention to detail.
  • Proven client facing experience.

About Us:

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

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

What's in it for you:

  • Highly competitive total reward packages
  • Wellbeing programmes
  • Development opportunities
  • Welcoming, friendly, supportive colleagues
  • A diverse and inclusive working environment
  • Our values are: Deliver Innovation, Be Inspiring and Have Integrity
  • State of the art laboratory and manufacturing facilities

We want you to feel inspired every day. We're future-focused and our business is growing rapidly. We succeed together through passion, commitment, and teamwork, and so can you.

Collaborate. Contribute. Change lives.

We offer:

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.

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