Senior QC Microbiologist

1 month ago

Oxford, United Kingdom Pharmiweb Full time

Job description:
 

We pride ourselves on our integrity. We do what’s right for our employees, patients and partners, and so can you.

 

We are currently recruiting for a Senior QC Microbiologist to join the team. The purpose of this role is to be responsible for oversight and performance of environmental monitoring within the manufacturing facilities (operating at ISO 8 to ISO 5 classifications), and the collection, testing and data analysis of raw material and product microbiological testing to ensure that both the product and the cleanroom environments where they are made are in suitable biocontamination control.

 

Your responsibilities in this role would be:

 

  • Supervise and support a team of microbiologists.
  • Plan, organize and perform testing of raw materials, in-process, intermediates and final product samples.  Testing includes environmental monitoring, bio-burden (membrane filtration) and endotoxin testing (LAL), sterility testing (within isolator), microbial identification, growth promotion testing, operator qualification and media qualification testing using varying standard microbiological equipment following SOP’s in order to comply with regulatory requirements.
  • Maintenance of microbiological test data.
  • Ensure the microbiology laboratory is maintained to GMP standard and equipment is calibrated, maintained, cleaned and monitored appropriately.
  • Write and review SOP’s/protocols/reports and other documentation to ensure compliance with required standards.
  • Ensure that quality documentation such as deviations, change controls and CAPA’s are raised and expedited to agreed timelines.
  • Review microbiology testing results to ensure data integrity.
  • Responsible for communicating and initiating any deviation or OOS micro results to manufacturing and other relevant departments in order to take corrective actions, and performing root cause analysis.
  • Communicating and scheduling with external engineers for equipment service and calibration without affecting business deadlines.
  • Represent the microbiology laboratory in communications with manufacturing and supply chain to synchronize microbial testing as and when required.
  • Support with aseptic fill finish processing microbiological testing activities. 

 

We are looking for:

 

  • Degree in Microbiology or other Life Science, or significant supplementing industry GMP QC Microbiology
  • Excellent knowledge of cGMP requirements with specific reference to documentation and laboratory activities in order to ensure compliance is maintained.
  • Good understanding and knowledge of practical and theoretical microbiology techniques and aseptic techniques in order to enable effective and accurate environment monitoring and microbial testing.
  • Thorough understanding of GMP and cleanroom biocontamination control.
  • Relevant experience in microbiology laboratory and GMP/clean rooms.
  • Monitoring regulatory/industry updates. 
  • Experience in bioburden testing, environmental monitoring, endotoxin testing, sterility testing, media qualifications, and growth promotion testing.
  • Working within ISO 8 to ISO 5 clean rooms and experience within aseptic fill finish activities.
  • Flexibility to work shifts during the hours of 07:00 to 03:00, Monday to Friday, with the possibility of occasional weekend shifts

 

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: Responsible, Responsive, Resilient, Respect
  • 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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