Device Technical Manager - (COMPANY NAME) Biomanufacturing Center

Descripción del puesto:

Are you a person who find inspiration in cross-functional and global collaboration? Are you looking for a chance to make a difference for people worldwide? Then your future starts with us!

The Sweden Biomanufacturing Center (SBC) is a strategic investment to support (COMPANY NAME)'s growing biologic product portfolio, it´s the primary launch site for Biological products.
At Sweden Biologics Center at (COMPANY NAME), we have a culture of tight collaboration, care for each other and our patients. Here, we shape the future of medicine by producing and delivering advanced and sustainable biological medicines to patients. We operate cross functional in an inclusive and global environment where digital solutions, our LEAN culture and Sustainability focus propel us forward. With us, you not only can think outside the box - you get to design your own box, build your own space, and develop your career. 

We now offer an exciting opportunity to join SBC with offices and plant located in Södertälje, as Device Technical Manager in the Combination Products & Packaging Technology team within our function Manufacturing Science & Technology.

Business Area
Manufacturing Science & Technology (MS&T) is the bridge that turns innovative science into actual medicines. The MS&T function ensures reliable and flexible formulation, filling, visual inspection, combination product final assembly and packaging of late stage clinical and commercial products. MS&T also participates in product maintenance and provide expert technical support for SBC's commercial product portfolio.

Within MS&T the Combination Products & Packaging Technology team is responsible for:
* Design transfer of combination products in late-stage development.
* Control strategy establishment from incoming component controls to IPC and final release.
* Product impact assessments in the establishment of assembly and packaging processes.
* Life Cycle Management activities, such as continuous improvements and root cause investigations.

As Device Technical Manager you will be part of a team with specialists in process development, transfer activities and manufacturing of Combination Products including accessorized prefilled syringes and auto-injectors.

The Device Technical Manager will work in close collaboration with AZ's global development sites to build up product knowledge and, based on the SBC process capability, assess the gaps which determines the scope of the product transfer. The product transfer activities are managed as projects and the Device Technical Manager will collaborate in project teams together with other functions at the site, e.g. Process Technology, Material & Artwork and Quality Control.

What you will do
You will serve as the Combination Product/Medical Device Subject Matter Expert (SME) for Design Transfer and Investment/Improvement Projects for new technology and capability builds. You will lead or participate as a Combination Product/Medical Device SME in risk assessments, change controls and deviation investigations in collaboration with external and internal customers and suppliers. You will also be the owner of SBC's Device Master Record for transferred combination products.

As SBC is expanding and invests in increased manufacturing capabilities it will also be a task for the Device Technical Manager to participate in the establishment and implementation of global platform standards for SBC's combination products.

Essential Requirements
* Professional experience in combination products/medical devices in late-stage development or manufacturing.
* Strong problem solving and analytical skills.
* Structured and excellent in technical writing (English).
* MSc degree or equivalent.

Desired requirements
* Understanding of combination product and cGMP regulations.
* Curious mindset.
* Experience in medical device risk assessments, statistics and tools for data analysis and Product Lifecycle Management

Why (COMPANY NAME)?
At (COMPANY NAME) when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines to our patients is about being entrepreneurial - finding those moments and recognizing their potential. Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we're opening new ways to work, pioneering cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey.

So, what´s next?
Don't miss this opportunity to join a company that truly values its employees and their contributions! Apply now and take the first step towards making a difference in the world of biomanufacturing.

For more information about the position please contact Viktor Larfeldt, Manager Combination Product & Packaging Technology at viktor.larfeldt@(COMPANY NAME).com
If you have questions about the recruitment process please contact responsible Talent Acquisition Partner Helena Kallin helena.kallin@(COMPANY NAME).com
Welcome with your application no later than May 26, 2024. Interviews will be held ongoing during the application period.

Do you want to learn more about who we are and what we do at the SBC? Look at our webpage and these films!
* Manufacturing Science & Technology (Manufacturing Science & Technology department)
* Sweden Biologics Center
* Sweden Biologics Center - what we do
* Sweden Biologics Center - Who we are

85002214

Date Posted29-apr.-2024

Closing Date26-maj-2024

Our mission is to build an inclusive and equitable environment. We want people to feel they belong at (COMPANY NAME) and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form