DESIGN CONTROL ENGINEER/SPECIALIST - CMC BIOLOGICS DEVICE AREA

Are you experienced with Design Control in late-phase and looking to join our growing team of Device and Combination Product Experts? And do you want to work with Devices and Combination Products in an international setting where empowerment and cross functional collaboration skills are key? Then you might be our new Design Control Engineer/Specialist!
Lundbeck has several development projects in pipeline requiring Combination Products with a Device constituent part. We implemented a first generation fit-for-purpose Quality Management System (QMS) and are in the phase of maturing our setup to support the future Combination Product development activities within Lundbeck.
The position provides a unique and rare opportunity for you to be part of building and shaping the future.

APPLY NOW

Can you see yourself as our new Design Control Engineer/Specialist and want to join our international team of Device and Drug Product Specialists?
Then upload your CV and include your motivation for applying. No separate cover letter is needed. We ask you not to include a photo or personal information that does not relate to your professional experience.
If you have questions, please feel free to contact Michael Torben Pedersen, Senior Director of Drug Product Technology, on MIPD@Lundbeck.com or (+45) 2944 5851.
Applications must be received by August 31, 2024 and will be reviewed on an ongoing basis.
We need every brain in the game – and that includes all brains and the different perspectives we bring to the table. At Lundbeck, we embrace the uniqueness of each employee, and we are committed to building a workforce that is as diverse as the people we serve. Read more about our commitment at www.lundbeck.com/global/about-us/our-commitment/diversity-and-inclusion.

EveryBrainInTheGame

This job ad is intended for individuals seeking a career opportunity with Lundbeck. We engage with recruitment and search firms where needed on the basis of a written agreement, and we do not accept unsolicited requests of any kind. If you work as a recruitment consultant, you are kindly instructed to refrain from contacting Lundbeck or the hiring manager directly with suggested candidates. If you violate this policy, you do so at your own risk and for your own account, and Lundbeck will not assume any liability nor pay any associated fees resulting from such violation.

In CMC Biologics, you will contribute to and facilitate a wide range of activities (for the Combination Product and Device Constituent Part) adjusted according to your interest and capabilities:

• General project documentation (late-phase Design Control documentation)
• Design reviews (Lundbeck, vendors and CMOs)
• Defining and maturing Combination Product Control Strategy
• Defining and maturing Manufacturing Control Strategy in collaboration with vendors, systems engineer, and QA
• Design Transfer to CMO and internal manufacturing site (specifications and agreements)
• Implementation of Incoming Control, Process and Release Specifications
• Process Validation covering Device Constituent Part in cooperation with our validation team
• Technical complaint handling
• Technical files (IND/CTA/BLA)
• Supporting regulatory filings and other interactions with Health Authorities
• Collaborate with Drug Product colleagues in department and project teams to define interfaces between drug constituent and Device constituen

As our Late-phase Design Control Engineer/Specialist, you are part of the project teams focusing on the Device constituent and contributing to establishing, reviewing, and maintaining late-phase project documentation with focus e.g., specifications, manufacturing specifications, design transfers, control strategies for Combination Products and cooperations with external partners.
You will also be an instrumental part of continuously developing and maturing our Device organisation, working procedures (QMS) and tools, this in parallel with delivering on project activities. You will work in close collaboration with colleagues across the organisation.

In CMC Biologics, you will contribute to and facilitate a wide range of activities (for the Combination Product and Device Constituent Part) adjusted according to your interest and capabilities:

• General project documentation (late-phase Design Control documentation)
• Design reviews (Lundbeck, vendors and CMOs)
• Defining and maturing Combination Product Control Strategy
• Defining and maturing Manufacturing Control Strategy in collaboration with vendors, systems engineer, and QA
• Design Transfer to CMO and internal manufacturing site (specifications and agreements)
• Implementation of Incoming Control, Process and Release Specifications
• Process Validation covering Device Constituent Part in cooperation with our validation team
• Technical complaint handling
• Technical files (IND/CTA/BLA)
• Supporting regulatory filings and other interactions with Health Authorities
• Collaborate with Drug Product colleagues in department and project teams to define interfaces between drug constituent and Device constituent

This position is a unique professional development opportunity, as you will be part of a cross functional area providing you the option to learn from other disciplines (like Drug Product) in an international environment, while building on your current skills within Combination Products.
You will be part of defining future Device options, development, and supply chain strategies of Device Constituent Parts within Lundbeck and work in an exciting interface with various internal and external stakeholders.