Senior QC Microbiologist, Maternity Cover

Position: Senior QC Microbiologist, 12 Months Maternity Cover
Location: Chiswick

Company description: OXB 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, OXB has more than 30 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 patients 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).

OXB 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. OXB'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.

Job description:

Sr Quality Control (QC) Microbiologist, 12 Months Maternity Cover Join Us in Changing Lives. At OXB , our people are at the heart of everything we do. Were on a mission to enable life-changing therapies to reach patients around the worldand were looking for passionate individuals who embody our core values every day:
Responsible, Responsive, Resilient, and Respectful . We are currently recruiting for a Senior QC Microbiologist to cover a period of maternity within the Quality Control team. The purpose of this role is to be responsible fortheplanningand performance of environmental monitoring within the manufacturing facilities, and the testing and data analysis ofallmicrobiological 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:
Responsible for scheduling, planning,organisingtestingand ensuring the microbiology laboratory ismaintainedto GMP standards. Represent the microbiology laboratory in communications withother departments and supportandparticipateininternaland external audits. To write, update and reviewdepartmental documentationandbe competent inwritingand executingmethod suitability studies. Supervise and support a team of microbiologistsand be the first point of contact. Responsible for training ofnew staffas a trainer and provide scientific background information to trainees. Responsible for thetimely,accuratecompletionand reviewof assay paperwork and reporting of results,monthly trend meetings and trend report writing.

Leadand implementcontinuous improvement initiatives to enhance working practices. Partake and lead investigations and root cause analysis meetings to helpidentifycontributory factors, assign root cause and corrective/preventative actions. We are looking for:
Degree level qualified in Microbiology or related subject and/orsignificantrelevant

GMP microbiologicalexperience Relevanthigh levelof microbiological laboratory technical and GMP/clean room experience. Good understanding and knowledge of practical and theoretical microbiology/aseptictechniques;
Sterility testing on finished product, Bioburden and Endotoxin testing. Thorough understanding of GMP and cleanroom biocontamination control. Advanced understanding of laboratory health and safety requirements. Greater understanding of regulatory requirements e.g. GMP, and/or Validation and Quality Management systems. Computer literate (Word, Excel) andhigh levelof familiarity with Microsoft Office software. Flexibility to work shifts covering the hours from 07.00am to 03.00am Mon-Fri

About Us:

OXB is a quality and innovation-led viral vector CDMO with a mission to…