Brookfield

Are you an experienced biopharmaceutical professional looking for a chance to make a positive impact on human health in a dynamic and growing environment? If so, CSL is looking for you! We are seeking a Senior Manager to lead the Global Pathogen Safety support program for our Seqirus vaccine division.

In this role you will work as part of a team responsible for providing pathogen safety support to the North American (NA) Seqirus manufacturing and development sites (Holly Springs, NC and Cambridge, MA) and providing global support on pathogen safety across the CSL Behring organization. You will be responsible for building a network of contacts with the Seqirus NA organization and developing the pathogen safety control strategies for the Seqirus vaccine platforms. You will build and maintain matrix relationships partnering across the Seqirus organization (with interface functions such as Technical Development, MS&T, Quality Assurance, Clinical, Regulatory, Pharmacovigilance, Commercial, Corporate Communications) and advise on development of pathogen reduction steps using a Quality by Design approach in collaboration with Technical Development for clinical and licensed Seqirus products. Due to the global nature of the position, you may periodically be required to participate in global telcon meetings outside of local business hours.

Responsibilities:

• Be the go-to person for pathogen safety of all Seqirus products, building and maintaining matrix relationships partnering across the Seqirus organization (with interface to functions such as Technical Development, MS&T, Quality Assurance, Clinical, Regulatory, Pharmacovigilance, Commercial, Corporate Communications)
• Responsible for the pathogen safety control strategy for Seqirus products from selection of starting materials, testing strategies and pathogen reduction steps to assure final product safety for patients. Raise Pathogen Safety awareness across Seqirus NA organization.
• Provide pathogen safety expertise to NA-Seqirus manufacturing sites including change control and manufacturing incident assessments, product risk assessments, segregation risk assessments, and audit support. Prepare and update pathogen safety documentation, risk assessments and regulatory submission documents (pathogen safety topics) for vaccine products.
• Actively participate and represent GPS on cross-functional project teams and global project teams. Deliver GPS strategy by creating a respectful and open communication environment. Requires working periodically outside of local business hours
• Lead local and global Pathogen Safety driven initiatives. Influence peers and leaders to implement state of art pathogen safety strategies across different vaccines platforms.

Qualifications:

• Postgraduate degree (preferably MSc or PhD) and / or extensive experience in Virology, Biochemistry, Biology or related field.
• Minimum 5 years of experience in biologicals R&D. Demonstrated ability to work across sites and across international teams is desired .

Competencies:

• Build and maintain matrix relationships partnering across the Seqirus organization: Interface with functions such as Technical Development, MS&T, Quality Assurance, Clinical, Regulatory, Pharmacovigilance, Commercial, Corporate Communications
• Change agent: Identify and communicate opportunities for change, persuade stakeholders impacted by changes, translate vision into strategy, and turn strategies into specific plans of action
• Teamwork: Demonstrated ability in managing highly effective teams. Fosters a working atmosphere conducive to collaborative efforts.
• Customer Service: Understands customers and takes a proactive approach to meeting their needs in an effective and timely manner. Builds and maintains effective working relationships and partners with customers.
• Communication: Excellent communicator capable of building collaborative working atmosphere, with cross-cultural sensitivity and flexibility to work in global teams.
• Initiative: Identifies opportunities and issues and proactively acts and follows through on work activities to capitalize or resolve them. Willingness to reach out across organization to identify resources and information needed to execute tasks.
• Strong Technical Writing Skills: Superior writing skills; excellent command of English language.

Our Benefits

We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.

About CSL Behring

CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.

We want CSL to reflect the world around us

As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.

Do work that matters at CSL Behring!