Vaccitech

The Company

 

Vaccitech plc is a fast-growing biotech company. At only six years old we already have a development portfolio of nine programmes, a partnered product that is in commercial production which has seen more than 3 billion doses administered worldwide and an IPO behind us. We are a publicly-listed clinical stage biopharmaceutical company that spun out of the University of Oxford’s Jenner Institute, one of the most prestigious vaccine research centres in the world. We discover and develop immunotherapeutic products and vaccines for the treatment and prevention of infectious diseases and cancer. Our achievements include co-inventing and jointly developing our COVID-19 vaccine candidate VTP-900, now Vaxzevria, which we assigned to Oxford University Innovation to facilitate the licensing of those rights to AstraZeneca. We run clinical studies to explore treatments for patients with HBV and HPV infections and are developing rapid and scalable manufacturing processes for our platforms.

 

In December 2021, Vaccitech acquired Avidea Technologies with exciting product candidates for oncology and autoimmunity based on the innovative SNAPvax platform, which has demonstrated unprecedented control over T cell induction. This gives us US operational presence in Maryland, complements Vaccitech’s established capabilities and reinforces our position as a fast-growing global leader in immunotherapies and vaccines. In March 2022, we opened Vaccitech's new UK headquarters, and the Company will have relocated to this state-of-the-art facility in the UK's leading science and innovation campus at Harwell. We conduct research globally and have ambitious plans in the UK and US, where we will continue to grow our teams over the coming months and years.

 

The role

 

Reporting to the Vice President of Quality Assurance, the QA Analytical Associate will be responsible for the reviewing and approval of Analytical documents. This role will also involve the direct day to day support for the Analytics and the Immunology Departments. The role will report to the Director of Quality Assurance (UK) but will work very closely with the Director of Quality (USA) to provide support remotely where required.

 

Key areas of responsibility will include, but are not limited to:

 

• Review of stability protocols and reports
• Review and approval of Analytical Plans, Analytical Reports and Analytical data
• Review and QA approval of Out of Specifications (OOS), Out of Expectation (OOE), and Out of Trend (OOT)
• Review and QA approval of analytical SOPs and other related procedures
• Vaccitech review of third party/outsourced analytical data and Certificate of Analysis, including those used for drug product release
• Support the internal and external (supplier) audit schedule especially with reference to Laboratories
• Review Quality Technical Agreements in place between Vaccitech and External / third party laboratories
• Support the supplier approval and assessment for new and existing suppliers especially with reference to laboratories
• Review and QA approval of Analytical Specifications
• Review and QA approval of Method Validation protocols and reports
• Review and QA approval of Reference Standard qualifications and requalifications
• Providing support and data to the Leadership Quality Review Meetings where applicable
• To support earlier stage analytical development, including review of method qualifications, analytical equipment/instrument qualification, method transfer, etc.
• To support other QA activities in the CMC department such as batch record reviews, Quality Events (Deviations), for example
• Support the QA department in maintaining compliance with our Quality Management System (CAPAs, Quality Events, Change Control, SOP management)

 

Experience and education required

 

The successful candidate will be degree educated in a scientific discipline with a minimum of three years’ experience working in a Quality Control (QC) environment. You will be an exceptional understanding of ICH guidelines pertaining to Stability (ICH Q1), method/ analytical validation for biologics and chemicals (ICH Q2 to ICH Q6, Q11, Q14, ICH M10) as well as method and assay qualification experience. Quality Assurance (QA) experience including experience of auditing, both internally and externally, is desirable though not essential. Experience in tech transfer of assays to outsourced laboratories is also desirable though not essential.

 

What we can offer you

 

Vaccitech is a great place to work. We encourage an entirely flat structure with an open-door policy to the senior leadership team. Our employees agree the culture and working environment is one of the best things about our business. This role would suit an experienced QC Chemist who wants to move into a QA career path. As part of a small high growth business you will get the opportunity to be involved in many different areas and our rapid growth trajectory means you will have the opportunity to grow with us. We offer flexible forms of hybrid working, stock options to all employees, 25 days annual holidays increasing with length of service, an AXA Healthcare plan, Life Insurance and up to 6% pension contributions matched by the company.

 

Notice to Recruiters

 

Vaccitech’s internal Talent Acquisition leads recruitment and employment for Vaccitech. Unsolicited resumes sent to Vaccitech from recruiters do not constitute any type of relationship between the recruiter and Vaccitech and do not obligate Vaccitech to pay fees should we hire from those resumes. Vaccitech operate a preferred list of recruitment suppliers, any and all enquiries about joining us as a supplier should be directed to Vaccitech’s TA Team. We ask that external recruiters and/ or agencies not contact or present candidates directly to our hiring manager or employees.