Director Content - Marburg, Deutschland - CSL Behring

Beschreibung

For our Biopharmaceutical Product Development (CMC) department, we are looking for a

As Director, CMC (Recombinant Proteins) you will lead specific Product Development Expert Teams (PDET) or CMC teams for multiple CSL Behring recombinant projects in either early or late-stage clinical development.

The primary responsibility and accountability of the role is to establish and manage the product development strategy and deliver the scientific content for the Quality Section of Health Authority submissions for the Project.

To accomplish this objective, the CMC Lead will provide direction, guidance, coordination and oversight of cross-functional, global PDET or CMC teams.

This is a senior leadership role within CSL Innovation's Biopharmaceutical Process Development (BPD) group, with responsibilities to intimately manage the PDET or CMC Team, ensuring goals are set, progress is formally measured and the requirements of the Project are met in terms of quality, cost and timeliness.

The role will work closely with the head of Biopharmaceutical Product Development (BPD) Marburg and their Leadership Team to ensure projects are prioritised and resourced appropriately and that there is a clear line of communication between BPD and the Product Strategy Team (PST).

This includes directing product development activities to meet these project-related targets.

You will represent BPD in the assigned PST forums, providing input to the Product Strategy Plans, identifying risks/constraints and ensuring timelines are developed to reflect the needs of the PST and BPD's capabilities and capacities.

Conversely you will ensure key decisions, risks and outcomes from the PST forums are clearly communicated to the relevant BPD functions.

You will provide oversight of process scale-up and transfer activities for the project, guide process/product characterization and comparability tasks after process changes and be responsible for development of process control strategy including development of product specifications.

As the product subject matter expert, you will ensure the overall product strategy is clearly communicated and followed through your interactions with key support functions such as, but not limited to, Process Engineering, Operations, QA/QC, Global Pathogen Safety and Technology Transfer.

Working closely with Global Regulatory Affairs (GRA) - CMC, you will ensure the completeness of scientific content within and the delivery of the Quality section for all Health Authority submissions.

This includes oversight and coordination of SME teams for compilation of dossiers, briefing books and associated HA interactions and responding to resulting questions in a timely manner.

Advance Science Degree (PhD or MSc in Biochemistry/Biology, BE), or

A minimum of 7 years of relevant experience in the development of therapeutic proteins including late-stage development activities such as validation and characterization studies.

You must have excellent and proven people management, communication and presentation skills including experience in managing complex cross-cultural communication between teams.

Innovative work-environment at our R&D campus
CSL-subsidized company bike leasing
For more information, please check out our global benefits below.

Please ensure to apply online with your CV and certifications as well as your salary expectation.

Our Benefits

CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases.

As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion.