PPD CMC Lead

About CSL

With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.

CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.

We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!

Job Description

Position Purpose

This senior leadership role will be responsible for project-specific Chemistry, Manufacturing and Control (CMC) teams accountable for CSL Plasma Product Development (PPD) projects. The primary responsibility and accountability of the role is to define and deliver contemporary CMC packages during Life Cycle Management (LCM) projects and potentially for clinical development and market authorizations.

To accomplish these objectives, the CMC Lead will provide strategic leadership, 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.

Responsibilities

• In close collaboration with R&D and operations, defines and ensures execution of appropriate process, analytical, and comparability programs
  
• For Life Cycle Management (LCM) projects, defines manufacturing operation development targets
  
• Oversight of process scale-up 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 cross-functional team.
  
• For clinical development, define needs based on non-clinical and clinical study designs and application
  
• Ensures alignment on and communication of CMC strategies, objectives, and deliverables
  
• Regularly reports to Core Project Teams, Steering Committees and established governance bodies on progress against deliverables, timelines, and project risks
  
• Reset priorities, request additional resources and make key decisions about directions for the CMC delivery teams
  
• Accountable for delivery of the content of the regulatory Quality Sections for the CSL Plasma Product Development projects including:
  
• Participating in the process scale-up and technology transfer activities within CSL Behring production sites;
  
• Contributing to the strategic aspects of product characterization, comparisons, manufacturing trending, trouble shooting and process changes, including a coordinated and well-structured dossier of reports;
  
• Maintaining line-of-sight for all other aspects of the development process in Validation, QA, QC and Engineering, including ensuring a consistent and coordinated approach to their respective studies and reports
  
• Ensures appropriate and continuous communication with Research, Development, and global CMC groups relating to topics interfacing with CMC and associated activities.
  
• Accountable for CMC/QbD related project and product documentation (for example: risk assessments, PFMEAs, monitoring strategies,...) in accordance with global CMC/QbD policies
  
• Executes globalization/ harmonization initiatives across sites that drive efficiencies, establishes best practices, and return values to CSL Behring.
  

Qualifications:

• Postgraduate degree (preferably PhD) and / or extensive experience in relevant industry or academic environment - scientific and technical
  
• Minimum 10 years of experience in pharmaceutical industry with emphasis on manufacturing operations, process design, and process validation.
  
• Demonstrated experience in project management and or leadership by influence preferred.
  
• Advanced knowledge of biological manufacturing processes and advanced CMC/QbD requirements for plasma derived or biotechnology therapies is preferred .
  
• Technical and regulatory writing experience.
  
• Previous experience working across sites and as part of international teams is highly desirable.