Associate Director/ Head of Analytical TT Strategy Recombinant (m/f/x) R-248368

or our Biopharmaceutical Product Development (BPD) division, we are looking for a

Associate Director/ Head of Analytical TT Strategy Recombinant (m/f/x)

R-248368
Fulltime / permanent/ non-tariff
The Head of Analytical TT Strategy (Recombinant) is responsible for supporting the Marburg and Melbourne BPD Recombinant early and late clinical phase Portfolio. Working with key BPD stakeholders, this role will refine and manage the BPD Recombinant Analytical outsourcing and TT Strategy. The role reports to the Director, Analytical Tech Transfer Strategy & Technical Project Management.
The Opportunity

• Key point of contact and Management of strategic partners for Contract Analytical Services including forecasting, reporting and oversight of budgets.
• Management of Biopharmaceutical Pharmaceutical Product Development (BPD, Recombinant) Analytical Outsourcing and Tech Transfer Strategy
• Executing Analytical strategic plans for BPD projects (Recombinants).
• Leading Tech Transfer of BPD analytical activities projects internally and externally
• Ensuring project requirements, both internal and external stakeholders are met with respect to quality, cost and timelines.
• Participate in due diligence activities for New Product Opportunities
• Utilise insights from the product development pathway and global biopharmaceutical trends to guide R&D policy, support preparation of regulator packages and identify new opportunities for cost savings and process efficiencies.

Your Skills and Experience

• Post graduate qualification in a relevant branch of Chemistry or Biological Science
• At least 10 years hands-on experience in Analytical Development and related process development activities.
• Understanding of and experience in the production and technology transfer of protein therapeutics including, chromatographic separation/fractionation of proteins and other methods of protein purification, formulation activities and associated analytics (in-process, characterization and GMP release methods), from bench-scale to clinical manufacturing scale
• Understanding of the regulatory requirements and compliance standards (FDA, EMA, JP, TGA) associated with GMP production of proteins for clinical development programs, process validation & characterisation required for BLA applications.

What we offer

• Excellent income potential and extended benefits
• Up to two additional leave days for your personal wellbeing
• Family services such as psychological support, legal advice, family care services and more for you and your direct family
• Hybrid working models

For more information, please check out our global benefits below
We are looking forward to your application. Please ensure to apply online with your, cover letter, CV and certifications as well as your salary expectation.

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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.

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