Senior Specialist, Drug Product Packaging

Do you have experience with secondary packaging in a GMPregulated pharmaceutical environment including development and lifecycle management Can you strike the balance between adhering to a well-defined set of regulations quality standards and execution with respect to timelines

If so now is your chance to join Ascendis Pharma as our new Senior Specialist Drug Product Packaging.

Ascendis Pharma is a global biopharmaceutical company committed to making a meaningful difference in patients lives. Guided by our core values of Patients Science and Passion we are applying our innovative TransCon technology platform to fulfill our mission of developing new therapies that demonstrate best-in-class potential to address unmet medical needs.

At our headquarters in Hellerup Denmark research facilities in Heidelberg Germany and additional offices across Europe and the United States we are advancing programs in our Endocrinology Rare Disease and Oncology portfolios. We also collaborate with partners on the development of TransCon-based products in other therapeutic areas and markets.

As Senior Specialist in Drug Product Packaging your main responsibilities will include creating artwork files for production preparing mock-ups for Regulatory Affair approvals related to submissions and product launches and maintaining and updating existing packaging materials. This role also provides the opportunity to act as a subject matter expert offering support for the development and ongoing maintenance of packaging.

You will report to the Senior Director of Drug Product Packaging.

Your key responsibilities:

• Create artwork files for production and regulatory submissions including launch materials.
• Maintain and update existing packaging materials.
• Collaborate with Regulatory Affairs on documentation updates.
• Provide SME support for the design verification and implementation of packaging solutions.
• Develop technical requirements and specifications for packaging components and concepts.
• Collaborate with external partners and CMOs.
• Assess and provide SME input to CMO change controls deviations and CAPAs related to packaging.
• Manage lifecycle activities and conduct rootcause analyses for commercial packaging issues.
• Plan and execute internal change controls.
• Contribute to manufacturing transfers by defining productionready specifications.

Ideally you hold an education as graphic designer combined with 10 years experience from working in pharma with print production pre-press or similar.

Qualifications required for the position include relevant experience in manufacturing and the pharmaceutical industry:

• Ability to work independently and across functional teams
• Background and experience in working with external partners
• Broad technical understanding
• Capability to advance multiple projects in a fast-paced environment
• Experience in design control change control deviation handling and CAPA execution
• Understanding of the applicable Artwork management processes for Drug Product Secondary Packaging
• Understand technical drawings (e.g. die cuts) design manuals
• Knowledge about artwork demands secondary packaging materials (e.g. labels leaflets cartons)
• Familiar with applicable regulations and standards (e.g. 21 CFR 210/211/820/ EMA scientificguidelineson the packaging ofmedicinal products ISO 14971)

You have excellent English communication skills both spoken and written and you are an advanced user of Adobe InDesign & Illustrator Veeva and Text verification tools and other relevant IT tools or systems.

As a person you have a high level of drive ambition and passion. You take initiative are persistent pay a high level of attention to detail and you are goal oriented. You are comfortable with a risk-based approach to decision-making in a dynamic environment in which priorities and drivers can change rapidly. You can communicate clearly with your peers and you are an active project player who cooperates closely with other departments within Ascendis Pharma. Finally you are quality driven open-minded robust able to stand firm and you like to have fun.

At Ascendis Pharma you will be part of a stimulating and informal innovative working environment where you will interact with both colleagues and partners to achieve our ambitious corporate goals.

Travelling: App. 0-10 days a year.

Place of work: Ascendis Pharma resides in a wonderful office facility in Tuborg Havn in Hellerup with a view of the harbor the canals and the sea.

For more details about the job or the company please contact Senior Director John Witthøft on M:.

Application will be evaluated when received so please apply as soon as possible

You can learn more about Ascendis by visiting our website

Applications must be submitted in English and will be treated confidentially.

A note to recruiters:

We do not allow external search party solicitation. Presentation of candidates without written permission from the Ascendis Pharma HR team (specifically from: Talent Acquisition Partner or Human Resources Director) is not allowed. If this occurs your ownership of these candidates will not be acknowledged.

Required Experience:

Senior IC