Our mission at Ori Biotech is to enable patient access to a new generation of life saving cell and gene therapies. We have created a platform technology which automates cell and gene therapy manufacturing and has the potential to help make these treatments affordable and widely available to patients at scale.
Revolutionary scientific breakthroughs are currently being made in cell and gene therapy (CGT) to treat all types of disease ranging from cancer to rare genetic diseases. The first products using these technologies have come to market, and currently, there are more than 1500 clinical trials underway to bring even more products to the patients who need them.
The problem is that while these treatments are amazing, they are very expensive and can only be produced in very small volumes. This is where Ori Biotech comes in. Ori Biotech’s founding team is made up of cell and gene therapy/ life sciences veterans and has the backing of some of the top VCs in the US and UK. Having just closed its £23M Series A funding round in August 2020, the company is entering a rapid growth phase bringing on new team members to service its growing customer base. This is an excellent time to join our world class team and be an integral part of bringing the Ori platform to market.
We are looking for a Chief Technology Officer to lead the technical development and shape the future vision for Ori’s manufacturing platform. In this role you will be responsible for the development and production of our core product, essential to the mission of the business.
As CTO your responsibilities will be as follows:
- Oversee external testing phase. You will own the clinical validation work, manage system performance review & lead next iteration of product development (MVP to finalised design)
- Own the vision and development of the product. Develop, implement and execute Ori’s MVP platform development and long-term vision of a fully digital cell and gene manufacturing platform
- Build a world-class team. Build, manage and mentor an in-house technical/engineering team who work alongside the scientific team to deliver solutions to Ori’s customers.
- Accountable for compliance with regulations. You will bring apply your experience with developing medical equipment, and ensure that Ori is compliant with all regulations and requirements (e.g. IQ, OQ, PQ, CE, ISO standards etc.)
- Experience in working with developing sterile products, familiar with sterilisation methods and standards
- Act as a thought leader. Represent Ori to the CGT technical ecosystem to reinforce Ori’s thought leadership position in CGT manufacturing technology
- Apply expertise and knowledge:
– Familiarity with EU Directive 2002/98/EC on human blood and blood products
– Understanding of FDA regulations around biological products (CFR 610)
– Understanding of FDA regulations on cell & tissue culture devices (CFR 864-C)
– Understanding of CFR 21 Part 11
– End to end patient manufacturing records (api expertise)
– Rapid in-trial process development (bioprocess modelling)
– Automate QA/QC (bio process modelling and QA/QC)
- You are passionate about Ori’s mission to enable patient access to a new generation of life saving cell and gene therapies
- You want to build a business from the ground up, and thrive in fast-paced, agile and unstructured environments
- You are self-motivated and have the ability to deliver on objectives
- You have experience working in cell and gene therapy (ideally), antibody bioprocessing and/or biologics manufacturing
- You have built and launched manufacturing technologies
- You will have experience building out B2B/ enterprise services and have worked in life sciences required
- You are a fluent English speaker
- BSc/BA in Computer Science, Engineering or a related field; MBA or other relevant graduate degree is a plus
- Proven experience in a CTO role or similar leadership role
- Knowledge of technological trends to build strategy
- Understanding of budgets and business-planning