Director, CMC (Recombinant Proteins) (m/f/x) - R-228207

Detailansicht des Stellenangebots Stellendetails zu: Director, CMC (Recombinant Proteins) (m/f/x) - R-228207 Director, CMC (Recombinant Proteins) (m/f/x) - R-228207KopfbereichArbeitBiochemiker/inDirector, CMC (Recombinant Proteins) (m/f/x) - R-228207CSL Behring GmbHVollzeitMarburgab 29.04.2024unbefristetHeuteStellenbeschreibung

For our Biopharmaceutical Product Development (CMC) department, we are looking for a
Director, CMC (Recombinant Proteins) (m/f/x)
Fulltime / permanent/ non-tariff

R-228207

The Opportunity

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.

The Role

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).
You will develop and manage the execution of the CMC strategy to meet the Target Product Profile for a given molecule and/or indication. 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.

Your Skills and Experience:

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 be independent and capable of working for extended periods without supervision.
Be able to deal with rapid change, have a strong customer service focus and be committed to high quality outcomes.
You must have excellent and proven people management, communication and presentation skills including experience in managing complex cross-cultural communication between teams.
You will require a detailed technical background in the scale-up of the expression, purification, formulation and testing of recombinant proteins.
Experience in technical writing including scientific protocols and reports plus the authoring of sections within Regulatory submissions.

What we offer

Innovative work-environment at our R&D campus
CSL-subsidized company bike leasing
Childcare “Kita Froschkönig” for up to 14 children (from 6 months till 3 years old)
Access to Gym facility on campus
2 Wellness days per year (additional paid time off)
Family services such as psychological support, legal advisory, family care services and more for you and your direct family
For more information, please check out our global benefits below.
We are looking forward to your application. Please ensure to apply online with your CV and certifications as well as your salary expectation.

Was wir bieten

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Über CSL Behring
CSL Behring ist ein weltweit führendes Unternehmen, das hochwertige Therapeutika für Menschen mit seltenen und ernsten Krankheiten entwickelt und vertreibt. Mit unseren Medikamenten für die Therapiegebiete Immunologie, Hämatologie, Herz-Kreislauf und Stoffwechsel, Atemwegserkrankungen und Transplantationsmedizin halten wir unser Versprechen, die Lebensqualität von Patienten in mehr als 100 Ländern zu verbessern. Erfahren Sie mehr über CSL Behring.
Wir möchten, dass CSL so bunt ist wie die Welt, in der wir leben
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