Cmc Lead

vor 1 Woche

Zürich, Zürich, Schweiz Swisslinx Vollzeit
On behalf of our client, an international Biotechnology company based in Switzerland, Swisslinx is looking for a CMC Lead.


This senior leadership role will be responsible for project-specific Chemistry, Manufacturing and Control (CMC) teams accountable for plasma product development (PPD) projects.

The primary responsibility and accountability of the role is to define and deliver contemporary CMC packages during clinical development, market authorization, and Life Cycle Management (LCM).


To accomplish these objectives, the CMC Lead will provide strategic direction, technical expertise, coordination and oversight of cross-functional, global and local CMC teams including representatives from Process Development, Analytical Development, Global Pathogen Safety, Technology Transfer, Quality, Regulatory Affairs, Validation, Manufacturing, and Quality.


  • Start date: September 2023
  • Duration: initially 2 years
  • Extension: possible
  • Remote work
  • Workload: 100%

Your mission:
In close collaboration with R&D and operations, define and ensure execution of the phase appropriate process, analytical, and manufacturing programs:

  • For Life Cycle Management (LCM) projects, define manufacturing operation development targets
  • Oversight of process scaleup and transfer activities
  • Responsible ensuring process/product characterization and comparability after process changes
  • Accountable for development of process control strategy including leading development of product specifications in a crossfunctional team
  • Ensure alignment on and communication of CMC strategies, objectives, and deliverables
  • Accountable for delivery of the Quality Section during clinical development, market authorization, and LCM changes for the CSL PPD projects
  • Accountable for CMC/QbD related project and product documentation (for example: risk assessments, PFMEAs, Process Control Strategies, ) in accordance with global CMC/QbD policies
  • Execute globalization/ harmonization initiatives across sites that drive efficiencies, establish best practices

Your Profile:

  • Education: PhD or MSc in Biochemistry, Pharmacy, Chemical Engineering or related field
  • Minimum 10 years of experience in pharmaceutical industry with emphasis on manufacturing operations, process design, and process validation
  • Demonstrated experience in project leadership by influence
  • Advanced knowledge of biological manufacturing processes and advanced, state of the art CMC/QbD requirements for plasma derived or biotechnology therapies
  • Technical and regulatory writing experience
  • Previous experience working across sites and as part of international teams is highly desirable
  • Patient safety strategies and GMP related aspects to ensure safety and efficacy of biological products
  • Biologics process development and validation
  • Advanced Quality by Design
  • Data Gathering, Analysis, Problem solving, Integrity

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