Senior Pharmaceutical Engineer

Who they are

aVaxMed Limited is a biotech based in Oxfordshire, United Kingdom, that has developed a novel needle-free solid-dose vaccine delivery technology. Their vision is a world where access to vaccines is universal, and population health is not impacted by preventable disease. Their mission is to transform the vaccine landscape by removing barriers to better vaccine uptake, such as cold chain logistics and needles and syringes. The technology consists of two key elements, the solid dose vaccine (SDV) and a needle-free pen administration system. The SDV contains the vaccine, formulated with stabilisers and structural agents to create a robust and thermally stable vaccine dose. This dose is then pre-loaded into a disposable cassette that is attached to a reusable spring-powered injector pen that rapidly delivers the dose subcutaneously with minimal sensation. aVaxMed solid-dose vaccine technology addresses many of the problems that lead to vaccine wastage and suboptimal vaccine uptake and significantly improves the performance of a wide range of vaccine candidates. The solid dose presentation offers excellent thermal stability, reducing wastage and greatly increasing the distribution reach of vaccines, particularly in LMICs, is needle-free by design, eliminating the risk of needle-stick injury and offers simple and rapid administration.

Job Description

To support the development of a robust, scalable manufacturing process for aVaxMed. To lead the engineering design, installation and operation of prototype equipment for R & D processes. To support external engineering contractors to ensure equipment delivery to specification, within both budget and timelines. To support the design of aVaxMed’s aseptic clinical manufacturing line and to supervise equipment installation and qualification at manufacturing (CDMO) contractor sites. To provide associated technical input to manufacturing processes and aVaxMed’s own facilities management.

key responsibilities
• Working with the Process Development and Operations teams, to provide engineering input and oversight for the engineering design, installation and operation of prototype equipment for R & D processes including (but not limited to) powder blending, solid dose compression, integrated device assembly and unit dose packaging.
• To ensure the provision and execution of User Requirements Specifications (URS) and Test Protocols.
• To support external engineering contractors (associated with the above) to ensure prototype equipment is delivered to specification, quality standards, budget and timelines.
• To prepare associated equipment Standard Operating Procedures (SOPs) and Calibration/ Maintenance Schedules. To train company personnel in associated procedures.
• To support the design of aVaxMed’s aseptic clinical manufacturing line and provide associated guidance for GMP manufacturing processes.
• To support the commissioning of new equipment at engineering contractors.
• Working with Regulatory, to support the GMP qualification of new equipment for clinical use at aVaxMed’s selected manufacturing contractor (s).
• To lead IMP packaging development to ensure suitability for sterile IMP clinical use.
• Working with Operations, to support the management of aVaxMed’s own facilities and support the purchase, installation, documentation and test operation of all R & D equipment requiring the preparation of a URS.
• Provide regular status updates on all projects (including project plans) to colleagues and management.
• Identify and report all potential risks and develop appropriate mitigation plans.
• Deliver technically appropriate, data-driven scientific reports to a suitable level of quality.
• Ensure that all activities and projects are run according to aVaxMed’s ISO13485 Quality System

The ideal candidate

Qualifications and experience

• B. Eng/ B.Sc degree or higher in engineering or relevant science.
• At least 5 years of experience working hands-on in pharmaceutical engineering, within a solid dosage form process development/ manufacturing environment, is essential.
• Ability to support external parties to achieve project objectives within agreed deadlines and budgets with a willingness to work as aVaxMed’s ‘person in plant’.
• Experience of GMP equipment qualification and process development/ industrialisation is desirable.
• Experience of designing/ developing equipment for powder blending, solid dose manufacture and packaging is essential.
• Experience in aseptic manufacturing processes intended for clinical use is desirable