AstraZeneca Pharmaceuticals LP Device Technical Manager - Operations in Macclesfield, United Kingdom
Competitive Salary & Excellent Benefits
We lead our industry in the development of a strong and varied pipeline. This means our people are here to win. We give you a breadth of opportunities to be curious and do cutting edge, unique work that has a big impact on science and medicine.
Global Operations at AstraZeneca brings innovation from our science labs to patients, touching every part of the business on the way through. As such, we have a pivotal role to play in helping our company embody its purpose and achieve its bold ambition.
AstraZeneca is recruiting a Device Technical Manager (DTM) role focussed on medical devices and combination products to be based at our Macclesfield site.
The DTM will work in Pharmaceutical Technology and Development, part of Global Operations. As a DTM, you will work collaboratively with Device Centres of Excellence, as well as providing expertise to other members of UK operations on-site and helping to enhance UK operations’ overall capability regarding technical aspects of devices and device management.
The role requires strong technical skills alongside project management, problem solving, and a good understanding of design control requirements.
Ensure device quality and manufacturability are built into the development process to ensure good process robustness from launch.
Understand and optimise performance of manufacturing operations through effective control of device specifications / variability relating to manufacturing process.
Provide expert support for device manufacturing sites to ensure quality and robustness of design history files and support sites with key DHF maintenance activities such as periodic risk reviews.
Ensure risk assessment/management is fully built into the development and product maintenance processes.
Provide product technical expertise to Operations sites that manufacture devices and external partners via appropriate channels e.g. Global Supply Chain, Global Quality.
Influence decisions at sites in respect to investments and asset utilisation.
Manage improvement initiatives and establish business processes and requisite supply chain and quality management for devices.
Identify and deliver continuous improvement initiatives for devices under own responsibility.
Device related technical support during the transfer of established products and major brands to external manufacturing partners in the region and transfer of projects to Operations.
Identify and deliver device related technical support for any major change initiatives (for example, sourcing and asset strategy driven changes).
Develop technical solutions to a diverse range of problems using structured problem-solving tools and sound analytical and conceptual thinking.
All these activities will have a significant impact on the overall success of Operations as well as ensuring the commercial viability of current device products. The activities of the team help to ensure availability of all AstraZeneca device products to the commercial organisation. The role, therefore, has an impact on both financial and reputational aspects of the business.
As part of growing our device capability, we are looking for a DTM that could develop experience across both device development and commercial manufacturing functions. Longer term, this role offers several different career development routes with options to continue in technical/project roles or move into other areas of the Operations business.
Required Skills & Knowledge
Demonstrable knowledge and manufacturing experience of the overall drug and device development and commercialization process from development, launch and through life cycle management.
Experience of working with devices as a device design engineer, device quality engineer or device manager working in operations and/or development.
Educated to BSc level with experience in an appropriate discipline and have professional credibility within the business and industry.
Understanding in the disciplines of Packaging and Device development, analytical, formulation and physical Science and global supply chain to identify appropriate solutions for management of devices and deliver value to the organization.
Thorough understanding of principles, applications and management of SHE, cGMP and Device standards and legislation (for example, FDA CFR 820 and EU MDD 93/42/EEC).
Experience in Operations and/or R&D with a track record of successful delivery within a matrix organization.
Evidence of excellent communication skills and building excellent relationships with customers and device component suppliers.
Project management and problem-solving skills with a thorough understanding of design work and design control procedures, such as risk analysis and design reviews associated with device legislation.
Please note applications must include your current CV and a cover letter.
Advert Opening Date: 22nd June 2018 / Advert closing date: 22nd July 2018
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, gender or gender orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law .