13 Oct
invoX Pharma
Great Britain
Job description
Description
The invoX Belgium NV, Respiratory Innovation Centre (RIC) is focused on the development of pharmaceutical products with superior delivery to the lung using the differentiated technology in our next generation Soft Mist Inhalation (SMI) device.
Our proprietary, propellant-free, purely mechanical device delivers medication to the lungs more effectively than other types of inhalers and is poised to change the treatment paradigm in large markets including asthma and COPD.
To help continue our growth and success, we are looking for a Senior Industrialisation Engineer .
This position will be focused on the development and deployment of industrialised aseptic fill-finish and associated process technology associated with invoX’s respiratory combination products.
As invoX continues to grow, this is a compelling opportunity to work in a fast-paced business.
This position can be based remotely in either the UK or Belgium, but will require time spent on site in Belgium and frequent travel to 3rd party sites
invoX is a research-driven global biopharmaceutical company using next-generation technology platforms to discover and develop innovative medicines that can change the lives of people around the world.
Our vision is to be a leading global biopharmaceutical company with an advancing pipeline of products addressing the unmet healthcare needs of patients.
invoX is a wholly owned subsidiary of Sino Biopharmaceutical Limited, a Hong Kong listed global top 40 pharmaceutical company with more than 24,000 employees.
Key Responsibilities
The Senior Industrialisation Engineer will report to the Head of Manufacturing Science & Technology, and will work with both internal functions, primarily Device Development and CMC,
external equipment vendors and contract manufacturing organisations.
Although it is expected this role will take the lead for aseptic fill-finish equipment, an involvement in component, device and primary packaging manufacturing / assembly industrialisation may also be required.
Accountabilities and responsibilities include, but are not limited to :
- Work collaboratively with the invoX RIC Device Development and CMC teams in the development of proof of principle, laboratory scale fill-finish and associated technology.
- Work collaboratively with the invoX RIC Device Development and CMC teams in the development of primary container / closure systems for invoX’s combination products.
- Develop and maintain a knowledge of state-of-the-art aseptic fill-finish technology / equipment through external contacts and disseminate internally as appropriate.
- Be the invoX subject matter expert on aseptic fill-finish and associated technology.
- Develop URS’s, RFP’s and RFQ’s for aseptic fill-finish and associated equipment / contract manufacturing requirements as necessary.
- Work with equipment vendors to develop and critique proposals, quotations, project plans, design documentation (such as FDS’s, HDS’s, SDS’s, FMEA’s) and validation documentation (such as IT / OT tests and protocols).
- Manage collaboration with equipment vendors throughout concept development, design review, manufacture, documentation development, site acceptance, transfer into manufacturing, factory acceptance,
site acceptance and validation activities in accordance with current good manufacturing practices.
- Work with the invoX Operations and Quality functions to select external CMO’s.
- Manage collaboration with selected CMO’s throughout equipment development, design, build, FAT, technical transfer from vendor into the manufacturing site, installation, SAT, validation and readiness for commercial manufacture.
- Support the invoX Quality function throughout equipment validation, readiness for manufacture and ongoing product quality oversight.
- Drive and support continuous improvement / COG’s reduction activities in collaboration with CMO’s and the invoX Operations function.
- Support invoX Device Development in the collation and management of the risk management and design control processes according to internal SOPs and regulatory guidance,
including the establishment and maintenance of Design History Files and Technical Files.
- Support Regulatory Affairs to prepare Medical Device / Combination Product preregistration documents and provide input to answer health authority questions.
Skills, Knowledge & Expertise
- A Batchelor’s or higher degree in Technology or Engineering.
- Considerable professional experience in a similar role within inhalation or parenteral device development / manufacturing industries and / or drug-device combination products.
- Aseptic Fill-Finish experience is essential
- Demonstrated success in the industrialisation and technical transfer of manufacturing / assembly processes.
- Demonstrated track record of project and people management skills.
- Experience of working effectively in a complex and matrix environment with multiple stakeholders and on cross-functional teams.
- Proactive, self-starter.
- Strong project and people management skills.
- Hands-on, problem-solver.
- Out of the box thinker.
- Able to multi-task, and to prioritize.
- Flexible, with an ability to manage change.
- Excellent communication skills, oral and written.
- Fluent in English, oral and written.
Experience in an international environment.
Ability to travel internationally on a regular basis.
invoX Pharma was incorporated in March 2021 and is a wholly owned subsidiary of Sino Biopharm, a Hong Kong listed, global top 40 pharmaceutical company with more than 24,000 employees.
UK-based invoX is an expanding biopharmaceutical company focusing on R&D;,
Clinical Development and Business Development activities in the UK, EU and US, with a core focus on oncology and respiratory therapeutics.
Our core team is made up of a multicultural international group of highly experienced individuals with life sciences and technology-centred backgrounds, all with a mutual passion and ambition for creating something different.
Mission : invoX’s mission by 2026 is to be a globally recognised, fully integrated pharmaceutical company with an advancing pipeline of innovative products addressing unmet healthcare needs.
Purpose We aspire to improve people’s lives by creating access to innovative medicine.
Vision : To be a leading global pharmaceutical company through delivering innovative therapies for patients.
▶️ Senior Industrialisation Engineer
🖊️ invoX Pharma
📍 Great Britain