The position will be accountable for establishing the Pathogens Safety (PS) strategies for the project portfolio of respective Integrated Product Teams (IPTs) such as Plasma-Derived Medicinal Products, Vaccines, Recombinants and ensuring that the pathogen safety data packages are executed in partnership with PS Laboratories and PS Support teams. You’ll be seen as a strategic thinker, a leader and influencer within Pathogen Safety and beyond. You will also be responsible for maintaining awareness of external trends such as emerging industry and regulatory best practice.
RESPONSIBILITIES AND ACCOUNTABILITIES
· Leads the development and execution of all aspects of Pathogen Safety strategy for respective product platform including requirements for starting and raw materials, virus and prion testing strategy definition, pathogen reduction footprint over manufacturing process and adventitious agents’ contamination control strategies for manufacturing facilities.
· Accountable for delivery of end-to-end overall safety strategies for all projects under respective IPT portfolio from defining pathogen safety measures to providing high quality packages to the regulatory authorities whilst adhering to industry standards and regulatory requirements.
- Provide strategic oversight of pathogen safety measures for all projects under respective IPT including overview of emerging industry standards, regulatory framework in areas of virus and prion safety, IP evaluation and due diligence support.
- Together with PS peers co-owns and maintains Pathogen Safety best practices as well as Pathogen Safety by Design framework and its implementation within the Pathogen Safety team and IPTs.
· Responsible for leading meetings within PS to track pathogen safety work packages and resolve technical issues and scientific questions pertaining to these work packages
· Defines virus/prion reduction targets for spiking studies to be executed internally or externally
- Together with PS peers co-owns and maintains Pathogen Safety best practices as well as Pathogen Safety by Design framework and its implementation within the Pathogen Safety team and IPTs.
· Communicates pathogen safety strategies and respective work packages to CMC leads and IPT leads as required
· Manages execution of pathogen safety work packages through strong partnership with PS Laboratories and PS Support teams in line with project timelines under the TechOps governance.
· If applicable, designs externalization strategy for pathogen safety measures through collaboration with PS support and respective IPT capabilities in a matrix format
· Tracks delivery of pathogen safety packages against integrated IPT schedule and reports progress to IPT as required
- Together with PS peers co-owns and maintains Pathogen Safety best practices as well as Pathogen Safety by Design framework and its implementation within the Pathogen Safety team and IPTs.
- Together with PS peers co-owns and maintains Pathogen Safety best practices as well as Pathogen Safety by Design framework and its implementation within the Pathogen Safety team and IPTs.
- Together with PS peers co-owns and maintains Pathogen Safety best practices as well as Pathogen Safety by Design framework and its implementation within the Pathogen Safety team and IPTs.
JOB SPECIFICATIONS
Education (Minimum education required for the role. This includes degrees, licenses, and certifications that are required to perform the job.)
- Postgraduate degree (preferably PhD) in Life Sciences
- undefined
Experience (Minimum years of experience and knowledge required to perform the job.)
- Minimum 7-10 years’ experience in a biological pharmaceutical environment
- A solid understanding of NPD and LCM in a Biopharmaceutical environment
- Proven track record in managing complex projects and strategy development
- Experience working in cross-functional, multicultural and international teams
Competencies (Measurable or observable skills, abilities, and behaviors critical to successful job performance.)
- Demonstrated strong leadership skills including the ability to influence others to accept practices and approaches
- Ignites agility and leads effective organizational changes.
- Thinks beyond and lead teams to respond in a fast-paced, ever-changing internal and external environment
- Build bridges and proactively improves cross-business collaboration
- Excellent communication and presentation skills (English) to both technical and non-technical audiences
Working Conditions
(Physical & mental requirements.)
- Possess change management leadership skills, and the ability to adapt to constant change and champion the Technical Operations dynamic working environment and continuous improvement initiatives
- Strategic thinker with a clear understanding of how goals and decisions align with the Technical Operations compelling business needs, ensuring delivery efforts are consistently value driven
- Able to maintain an external and strategic focus
· Excellent decision-making ability, especially with limited information and under ambiguous circumstances.
- Able to maintain an external and strategic focus
Travel Requirements (Domestic, International, frequency)
- Able to maintain an external and strategic focus
About CSL Behring
CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.
Our Benefits
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
You Belong at CSL
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.
To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.
