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) Director level MSAT professionals to join our newly established Global MSAT Team based from either our Oxford, UK, Strasbourg/Lyon, France or Cambridge, MA, US locations. 

The purpose of the role is to lead the implementation and maintenance of OXB’s analytical platforms and all analytical aspects of Client’s Programmes across the global network. The role will focus in areas of analytical harmonization, new technology introduction, continuous process improvement, and cross site analytical transfers, working closely with the site functional teams. It will also provide support for the analytical aspects of Client regulatory submissions, providing appropriate source documentation and performing reviews of the relevant sections of the regulatory documents.

Your responsibilities in this role would be:

• Develop and oversee rollout and implementation of harmonization projects into the Global network sites, developing deployment plans cross functionally and supporting the on-site teams during all phases of transfer to meet business targets
• Lead on assigned global project implementation initiatives to sites and ensure all project timelines and objectives are consistently monitored and delivered
• Strengthen, standardise and drive consistency in execution across OXB’s global network, with tactical focus on the company’s varied complex activities and multi-vector strategy
• Develop and define OXB’s strategies for transfer of new analytical platforms & processes and new technologies and lead implementation with the site teams
• Oversee analytical technology transfers for early stage/late stage/commercial projects, including PPQ campaign support
• Provide technical leadership and know-how directly with cross functional teams across the OXB operations network and strengthen cross-site support and SME knowledge sharing
• Identify improvement projects to enhance capabilities and resolve current and future challenges on integrated continuous processes, analytical automation
• Responsible for ensuring analytical process network alignment through platform strategy documents and business process.

We are looking for:

• Degree in Science / Engineering or related technical discipline, or equivalent level of work experience
• Extensive knowledge and practical experience of technical areas relevant to viral vector CDMO technologies and commercialisation
• Proven proficiency in supporting regulatory submissions
• Significant industrial experience in industrialisation of GMP assays, technical support & process troubleshooting
• Recognised SME in a technical field of expertise covering areas such as technology transfer, analytical assays, and analytical validation
• Strong expertise in understanding, utilizing, and integrating various analytical techniques with the ability to assess and recommend the best tools and technologies for business needs
• Experienced project manager, with skills in developing staff and/or processes and managing resources,
• Excellent communication skills with the ability to work effectively and influence in diverse and interdisciplinary teams both internally and externally with customers.

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.

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.

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

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.

Apply Here

• Manage with the relevant stakeholders, the creation and revision of the Global Documents (including Quality Policies, Global SOPs, and Guidelines, etc.) which support an end-to-end management of the quality processes
  
• Establish (for new entities), maintain, and develop Galderma's global Quality Management System through the electronic Quality Management System (eQMS) and the electronic Document Management System (eDMS) while ensuring compliance with the government regulations. Ensures the qualification status of these tools is kept current.
  
• Establish, develop, and maintain in collaboration with relevant stakeholders and Managers the appropriate training plans for the teams using our global Learning Management System (gLMS). Ensures the qualification status of this tools is kept current.
  
• Establish, develop, and maintain in collaboration with relevant stakeholders and Managers the appropriate Quality KPIs, targets and reporting ensuring an ongoing monitoring of the quality processes performance.
  
• Develop, maintain and improve templates for Quality KPI Dashboards, Quality Management Reviews and participates in Global Quality Reviews (preparation and presentation as needed)
  
• Prepare, manage and maintain an annual audit program ensuring vendors oversight in the areas of cGMP, GDP, ISO, Medical Devices regulations. Ensure the attainment of the annual audit plan. Ensure the auditor qualification program while maintaining enough qualified auditors.
  
• Ensure a regulatory surveillance of the evolution of the applicable government regulations (including cGMP, GDP, ISO, Medical Devices regulations or any other relevant regulations and guidance and guidance)
  

• Background in Medical Device, pharmaceutical or biopharmaceutical industry.
  
• A demonstrated knowledge and execution of Quality System Management.
  
• Knowledge of electronic training management systems
  
• Knowledge of different regulations:
  
  • Medical Device applicable regulation (NF EN ISO 13485; CMDCAS; directive 93/42/EC; 21 CFR 820, ...).
    
  • GMP (FDA, EU, ICH, PICs regulations, cGMPs related to all major territories),
    
  • GDP regulatory requirements.
    
• Solid background in MS-Office suite and other IS tools.
  

• You will be working for an organization that embraces diversity & inclusion and believe we will deliver better outcomes by reflecting the perspectives of our diverse customer base.
  
• You will receive a competitive compensation package with bonus structure and extended benefit package.
  
• You will be able to work in a hybrid work culture.
  
• You will participate in feedback Loops, during which a personalized career path will be established.
  
• You will be joining a growing company that believes in ownership from day one where everyone is empowered to grow and to take on accountability
  

• Send your CV in English.
  

• If your profile is a match, we will invite you for a first virtual conversation with Talent Acquisition.
  
• The next step is a virtual conversation with the hiring manager.
  
• The final step is a panel conversation with the extended team.
  

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 looking for a talented GMP Production professional to lead a team of Biotechnologists and achieve the production schedule whilst maintaining GMP, safety and environmental compliance.

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

Your responsibilities in this role would be:

• Taking accountability for the performance and Line Management of a team of Biotechnologists
• Co-ordinating production activities and requirements with other departments in order to achieve the production schedule with minimal disruption to other activities within the facility, this will require to be on a ‘on call’ rota.
• Ensuring that all work within the manufacturing facility is carried out in compliance with the facilities GMP procedures.
• Acting as a Subject Matter Expert (SME)for facility SOP's and batch documentation, CAPA / Dev / Change Controls, and regulatory / customer GMP audits. 
• Deputising for Production Manager approval on quality documents.
• Leading all manufacturing processes within the GMP facility.
• Trainer and SME on core manufacturing activities.
• Leading process/continuous improvement projects to increase the department’s efficiency.
• Promoting ownership and Continuous Improvement.
• Proposing and where required adopts new technologies to improve efficiency / reduce risk.
• Organising team training and review / approve training records.

We are looking for:

• Graduate in a science-based subject, and/or experience of working to GMP standard within an aseptic environment.
• Knowledge of Lenti Viral Vector Manufacture is desirable.
• Previous biological/chemical manufacturing experience in an MHRA /FDA regulated environment.
• Demonstratable ability to lead and manage a team.
• Robust problem-solving skills with the ability to make informed decisions.
• Excellent verbal and written communication skills, with a strong knowledge of MS Office applications.
• Flexibility to work varying shift patterns (shift allowance payable).

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.

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.

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.

Apply Here

• Extensive experience in a Clinical Research field (pharmaceutical industry or CRO) or other relevant experience in the areas of QMS support required
• Knowledge of Good Practices (GxP) compliance required
• Project Management / Technology / Business Operations experience, as appropriate, preferred
• English proficiency (written and oral)

• Good interpersonal, verbal and written communication skills including effective listening, facilitating group discussions, influencing without authority and providing appropriate feedback.
• Ability to plan, organize, prioritize and manage workload with LM guidance, keeping the patient and client at the focus.
• Quality oriented with an attention to detail, taking initiative, ownership and accountability for deliverables
• Cultural awareness with the ability to think and work, globally

• Bachelor’s Degree is required (Life-science, health or industry-related discipline preferred)