Team Lead, Analytical Development & QC

Job description:

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

We are currently recruiting for a Team Lead to join the Analytical Development and Quality Control team. The purpose of this role is to lead a team of Scientific Assistants, effectively co-ordinate the daily activities to ensure ADQC timelines are met whilst maintain compliance with GMP & safety regulations.

Our Analytical Development and Quality Control supports the development of products through analytical testing to facilitate manufacturing and process development, ensuring appropriate quality controls and use of analytics.

This role will be working across the ADQC scientific teams providing lab-based activities, including scheduling of cleans, equipment maintenance, tissue culture to provide laboratory support to aid and facilitate QC batch release as well as development, investigational work, and analytical validation.

Your responsibilities in this role would be:

• Responsible for the line management of a team of scientific assistants.
• Set individual objectives and perform informal and formal performance reviews.
• Support recruitment of new staff and the necessary onboarding activities
• Organise and co-ordinate cleaning and maintenance activities to required timescales in a compliant manner.
• Organise cell line maintenance, reagent, standard and control materials preparation and qualification to support QC assays for Analytical Validation and QC release in accordance with GMP regulations.
• Organize and conduct training, review and approve training records.
• Contribute to and/or lead troubleshooting and investigations.
• Contribute to and/or lead both departmental and company initiatives/projects.
• Completion and review of quality records (deviations, CAPAs and change controls) in a timely manner.
• Write and review ADQC Policies, SOPs, and forms.
• Responsible for ensuring the GMP compliance of the laboratory and equipment.
• Deputise for the QC manager where required.
• Support customer and regulatory inspections and attend Customer meetings.

We are looking for:

• Educated to BSc level with relevant experience, preferably including experience within a GMP environment.
• Laboratory technical experience and highly competent of the following areas: cell culture and qPCR.
• Ability to work within GMP regulations and maintain compliance; previous experience of working within a GMP environment.
• Understanding of laboratory health and safety requirements.
• An understanding of Virology and Cell & Gene Therapy,
• Demonstrable ability to manage others.
• Strong organisational and time management skills.
• Good attention to detail.
• Ability to prioritise workload and work under pressure.

About Us:

OXB 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.

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

Profile description:

The purpose of this role is to lead a team of Scientific Assistants, effectively co-ordinate the daily activities to ensure ADQC timelines are met whilst maintain compliance with GMP & safety regulations.

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.

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'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.