PPD CMC Lead - Melbourne Australia

Company: Confidential
Your Application: You have not applied yet
Location: Melbourne Australia, Australia
JOB DESCRIPTION

PPD CMC Lead
CSL Behring
PPD CMC Lead

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 the second largest influenza vaccine company 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!
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.


Worker Type:
Employee
Worker Sub Type:
Regular

CSL Behring
PPD CMC Lead

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 the second largest influenza vaccine company 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!
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.


Worker Type:
Employee
Worker Sub Type:
Regular

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Posted On

14 April 2021 22:
37

Start

14 April 2021

Location

Melbourne, Australia

Arrangements


Full-Time Flexible

Industries

Science & Biotechnology

Find out more about
CSL Behring






JOB TYPE
Work Day: Full Time
Employment type: Permanent Job
Salary: Negotiable


JOB REQUIREMENTS
Minimal experience: No experience



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