Posted 8 October 2018
Advent Pharmaceuticals is a small, dynamic company based in Melbourne that specialises in the development and commercialisation of complex generic inhaled products for the global pharmaceutical market. We aim to develop robust and quality products to meet exacting regulatory standards, by utilising sound scientific principles. We strive for scientific excellence and project delivery within a fast-paced, yet informal environment, where everyone’s contribution is valued. We work in collaboration with external partners across the globe to bring new, affordable and innovative products to the market for the benefit of patients.
Role and responsibilities
This is a rare leadership opportunity in Pharmaceutical R&D based in Notting Hill, Melbourne. The position of Head of Device Development has responsibility for all device development activities within Advent for generic combination drug-device inhaler products for US and global markets. The role entails component / device design, reverse engineering, tool development, component manufacture and device performance verification, spanning all phases from initial device concept through to technology transfer, industrialisation and scaling up to commercial manufacture.
The role forms an important part of the multi-disciplinary project team that defines the strategy and drives development projects forward to regulatory submissions and commercialisation. Working with formulation, analytical, regulatory, clinical, project leadership and quality functions, you will ensure that all time, cost, quality, regulatory and commercial manufacturing requirements are met.
You will lead and oversee a broad network of external experts who are engaged in the development, industrialisation, scale-up and commercial manufacture of Advent’s devices. Through the development of strong relationships, you will be responsible for ensuring high technical standards and timely delivery. A key part of the role is to identify and set up an effective commercial supply chain for the device aspects of drug-device combination products.
You will be a key member of the Advent Leadership Team, contributing to the definition and delivery of company objectives, leading by example and driving improvements in culture and systems.
You will maintain up-to-date knowledge of regulatory and quality guidelines relevant to the device aspects, including Design Control requirements. You will ensure the standards of work adhere to relevant GMP, data integrity and other global quality standards, working towards readiness for audits, GMP inspections and FDA pre-approval inspections. You will also manage the budget for the device programs, working with Finance and will seek to optimise the cost base by implementing efficiencies and smart ways of working.
You have a minimum of a Bachelor’s Degree in Engineering or a related Life Science discipline with at least 10 years’ experience in leading the design, development, industrialisation and/or manufacturing activities for medical devices, drug-device combinations or device-based diagnostics in the pharmaceutical, biotech, medical devices or healthcare diagnostics industry. You will have a successful track record of achievements, which ideally includes inhaled products and dry powder inhalers.
You have previous experience in leading teams (internal or external), underpinned by excellent leadership skills, combined with the ability to set clear strategies and objectives and to uphold the standards required for global registration and manufacture of inhaled products. You have excellent organisational and interpersonal skills and are confident in building relationships and liaising at all levels, both internally and externally.
You are results-driven with a can-do attitude that fits in with a fast-paced, collaborative and informal team environment. You have excellent problem solving and analytical thinking skills and are able to be creative / innovative within an entrepreneurial environment. You take pride in your excellent written and verbal communication skills and quickly learn and perform in an environment of high compliance.
Please send a cover letter and your resume (CV) to email@example.com