Senior Project Manager - Drug Product Packaging

Do you have experience within secondary packaging, and want to be part of a fast-growing company?

Can you strike the balance between adhering to a well-defined set of regulations, quality standards and execution with respect to timelines?

Ascendis Pharma, a visionary and ambitious company, offers you an opportunity to become a key player in supporting and developing the packaging area part of Product Supply & Quality.

As Senior Project Manager, the main criterion of success is to establish, review and maintain requirements/specifications, risk analyses and procedures needed to ensure safe products and efficient manufacturing processes within packaging. You will be an instrumental part in development, design optimization, design transfer, technical support and life-cycle management related activities for secondary packaging.

You will report to the Director of Drug Product Packaging.

Your key responsibilities:

• Project management in connection with tech transfer to CMO’s
• SME assessment of and input to CMO's change controls, deviations and CAPAs related to packaging
• SME support and approval during development (design), verification, validation and implementation of packaging designs including serialization
• Life cycle management and root cause analyses for failures for commercial packaging
• Develop, review and approve qualification and validation documentation of machinery, IT systems and work processes (FAT, SAT, IOQ and PQ).
• Develop Technical Requirements and Specifications for packaging components and concepts
• Develop, execute, and report verification methods and testing in cooperation with external partners being CMOs and test facilities etc.
• Participate in technical and design reviews for combination products
• Participate in transfers from development to manufacturing - translation of design outputs into production specifications
• Plan and execute internal Change Controls
• Write or review regulatory documentation for packaging

Ideally, you hold a relevant bachelor’s or master’s degree combined with 10+ years of experience from working with secondary packaging development, product transfers, product maintenance and manufacturing.

Qualifications required of the position include having relevant manufacturing and pharmaceutical industry experience are:

• Project management certification PRINCE2 or alike
• 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
• Experience with qualification and validation activities (FAT, SAT, IOQ and PQ).
• Understanding of the applicable manufacturing/testing processes Drug Product Secondary Packaging and manufacturing processes
• Understand technical drawings (e.g. die cuts), design manuals
• Knowledge about artwork demands for secondary packaging materials (e.g. labels, leaflets, cartons)
• Familiar with applicable regulations and standards (e.g. 21 CFR 210/211/820/, EMA scientific guidelines on the packaging of medicinal products, ISO 14971)

You have excellent English communication skills, both spoken and written, and you are an advanced user of MS Office, Access 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 deliver on our ambitious corporate goals.

Travelling: App. 10 - 25 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 Director of Drug Product Packaging, John Witthøft on m: +45 22 49 50 98.

All applications must be in English and are treated confidentially.

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

Hellerup