Full-Time
CSL
10,001+ employees
Develops biotherapies and influenza vaccines
No salary listed
Senior, Expert
King of Prussia, PA, USA + 1 more
More locations: Holly Springs, NC, USA
This is a hybrid role, which offers a combination of an onsite and remote work schedule.
- Valid, unexpired Customs Broker license
- A Bachelor's Degree is required; Masters in related field or equivalent is preferred
- Excellent written and verbal communications skills in English
- 10 years of progressively responsible experience in highly regulated, multi-location environments, cross functional experience is preferred
- Experience in managing complex Customs and trade Operations
- Expert in Customs and Export controls regulations, HTS and Explanatory Notes, rulings, court cases, and Customs Valuation rules, as well as a thorough knowledge of entry processing, international freight industry standards and practices, and INCOTERMS
- Skilled with special Customs programs (including FTAs, Drawback, FTZs, Value Reconciliation, etc.)
- Experienced in drafting formal Customs correspondence
- Excellent skills in organization, prioritization, and negotiation; must excel under pressure
- Able to motivate others to drive peak performance
- Must be self-motivated, goal oriented, and able to work independently in producing results
- Proficient with: Microsoft Word, Excel, PowerPoint with ability to develop skills with other programs as required
- Understands Quality systems and importance of systems, operational excellence culture and behavior to organizations
- Strong leadership skills (e.g. priority setting, timely decision-making, business acumen and dealing with ambiguity)
- Clear understanding of CSL's operating model and culture
- Ability to analyze and utilize data to drive decisions and priorities
- Able to influence and challenge senior leaders and peer groups
- Comfort around senior management
- Experience in understanding industry trends and changes to practice standards so CSL remains an industry leader
- Strong organizational, negotiation and influencing skills
- Displays strong level of engagement at all levels of the organization and does not only operate at a corporate level.
- Monitor regional key industry developments, legislative, and regulatory changes affecting CSL businesses, assess impact and represent CSL in various Trade Associations to ensure CSL’s interests are represented
- Implement CSL Global Trade Compliance Policies, guidelines, develop and deploy regional and local procedures, monitor the compliance readiness of the region through the management of the CSL import and export compliance risk-assessment, on site compliance reviews (audits), and support all external audits
- Drive KPIs, Trade data reporting, duty spend and duty savings, continuous improvement and drive efficiency throughout the import and export processes
- Oversee customs brokers in the region :KPIs, SOPs, contract, performance, lead regional bid and selection with procurement team
- Lead regional and local teams, responsible for all regional Trade and customs operations
- Responsible for the region record keeping ensures completeness as per regional, local requirements and CSL internal Policy
- Oversee HTS and ECCN classification as well as database, responsible for origin and preference determination, customs value and duty program utilization as per CSL Policies
- Identify risks and opportunities in the region and report to the Global TC team
- Support Government audits.
- Masters in related field or equivalent is preferred
- Cross functional experience is preferred
CSL develops and delivers biotherapies and influenza vaccines, focusing on rare and serious diseases. Their products include plasma-derived and recombinant therapies, which are manufactured and distributed to healthcare providers, hospitals, and governments worldwide. CSL's business model is centered on research and development, allowing them to offer a wide range of quality therapies. What sets CSL apart from competitors is their extensive portfolio and commitment to saving lives, as well as their emphasis on diversity and inclusion within their workforce. The company's goal is to protect health and improve the quality of life for patients through their innovative treatments.
Company Size
10,001+
Company Stage
IPO
Headquarters
Parkville, Australia
Founded
1916
Simplify's Take
What believers are saying
- CSL's gene therapy HEMGENIX shows sustained efficacy and safety over four years.
- KOSTAIVE vaccine demonstrates superior immunogenicity and antibody persistence for up to 12 months.
- CSL's performance-based reimbursement model for HEMGENIX sets new standards in Germany.
What critics are saying
- Emerging competition in gene therapy could impact CSL's market share.
- High costs of gene therapies like HEMGENIX may face pushback from healthcare systems.
- Reliance on plasma-derived therapies exposes CSL to plasma supply shortages.
What makes CSL unique
- CSL offers the first gene therapy for hemophilia B, HEMGENIX.
- CSL's KOSTAIVE is the first self-amplifying mRNA COVID-19 vaccine approved in Europe.
- CSL's diverse portfolio includes plasma-derived therapies, recombinant therapies, and influenza vaccines.
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Benefits
Health Insurance
Dental Insurance
Vision Insurance
Life Insurance
Disability Insurance
401(k) Retirement Plan
401(k) Company Match
Paid Time Off
Paid Vacation
Paid Sick Leave
Paid Holidays
Company News
Vienna, Austria – 9 April 2025 - CSL Behring Austria today announced that the first haemophilia B patient in Austria was treated with the gene therapy HEMGENIX® (etranacogene dezaparvovec) at the Comprehensive Care Center of the University Hospital of Medicine Vienna.HEMGENIX® is the first one-time gene therapy approved in Europe for the treatment of adults with severe and moderately severe haemophilia B, an inherited bleeding disorder caused by the lack of Factor IX (a protein needed to produce blood clots to stop bleeding). It is used in adults without a history of Factor IX inhibitors.1“It is a great opportunity for people with hemophilia B to live a symptom-free life for many years,” explains hematologist Univ.-Prof. Priv.-Doz. Dr Cihan Ay from the Medical University of Vienna, University Clinic for Internal Medicine I Clinical Department for Hematology and Hemostaseology."For the community of affected patients and their families, this represents an enormously significant milestone: the ability to treat hemophilia with gene therapy, and the fact that this option is now available in Austria, is something our community has been eagerly anticipating and hoping for over decades," says Thomas Schindl, MA, Chairman of the Austrian Hemophilia Society (ÖHG)."We are proud and grateful to offer haemophilia B patients in Austria a treatment option that has the potential to transform their lives," said Dr Beate Natmessnig, Managing Director of CSL Behring Austria. "This achievement is the result of outstanding regional and national collaboration among all parties involved and is a strong testament to Austria's innovative capabilities."HEMGENIX® was granted conditional marketing authorisation by the European Commission (EC) for the European Union and European Economic Area in February 2023, following approval from the U.S. Food and Drug Administration (FDA) in November 2022
Marburg, Germany, 2 April 2025 – CSL Behring and the GKV-Spitzenverband (National Association of Statutory Health Insurance Funds) have successfully concluded negotiations on the reimbursement price of HEMGENIX®. This agreement marks the availability of the first gene therapy approved in Europe for haemophilia B under an innovative, national, success-based reimbursement model, being implemented for the first time in Germany.HEMGENIX® represents significant progress in the treatment of haemophilia B. The aim of this one-time gene therapy is to eliminate the need for regular factor IX infusions, thereby offering patients the possibility of more freedom from prophylaxis and significantly improving their quality of life.1-4 This development not only provides substantial relief for those affected but also has the potential to reduce long-term costs for the healthcare system.‘The performance-based payment model at national level which was agreed with the GKV-Spitzenverband is unique in Germany. It addresses key reimbursement challenges, such as the question of long-term efficacy, which is inherent for any one-time therapy. Reimbursement is linked to treatment success of the individual patient,’ explains Stefan Neudoerfer, CSL Behring's chief negotiator in Germany.Moreover, this reimbursement model reflects the high therapeutic and innovative value of HEMGENIX® and sets new standards for integrating innovative gene therapies into the German healthcare system.‘The agreement on the reimbursement price of HEMGENIX® is a decisive step for the care of people with haemophilia B in Germany. It enables access to a groundbreaking therapy and recognises the long-term medical and economic benefits of gene therapy,’ explains Christian Wieszner, Managing Director of CSL Behring Germany.With this agreement, CSL Behring is underlining its commitment to innovative therapies that sustainably improve the lives of patients
- KOSTAIVE represents a significant advancement in vaccine technology, demonstrating superior immunogenicity and antibody persistence for up to 12 months post-vaccination compared to conventional mRNA COVID-19 vaccines in clinical trialsWALTHAM, Mass. and SAN DIEGO, Feb. 14, 2025 /PRNewswire/ -- Global biotechnology leader CSL (ASX: CSL; USOTC: CSLLY) and sa-mRNA pioneer Arcturus Therapeutics (Nasdaq: ARCT) today announced that the European Commission has granted marketing authorization for KOSTAIVE ® (ARCT-154), a self-amplifying mRNA COVID-19 vaccine, for individuals 18 years and older. KOSTAIVE is the first sa-mRNA COVID-19 vaccine to receive approval from the European Commission (EC). KOSTAIVE is currently marketed in Japan against COVID-19
94 percent of patients eliminated factor IX prophylaxis and remained free of continuous prophylaxis through four years post-treatmentMean factor IX activity levels were sustained at near normal levels of 37% through four years post-treatment, reinforcing the efficacy of HEMGENIX in the treatment of hemophilia BPhase 3 HOPE-B data showed that a one-time treatment with HEMGENIX provided long-term bleed protection as mean adjusted annualized bleeding rate (ABR) for all bleeds was reduced by approximately 90% from lead-in as compared to year fourKING OF PRUSSIA, Pa., Feb. 7, 2025 /PRNewswire/ -- Global biotechnology leader CSL (ASX:CSL; USOTC:CSLLY) today announced the four-year results from the pivotal HOPE-B study confirming the long-term durability and safety of a one-time infusion of HEMGENIX® (etranacogene dezaparvovec-drlb) for adults living with hemophilia B. In an oral presentation at the 18th Annual Congress of the European Association for Haemophilia and Allied Disorders (EAHAD), data showed that through four years, HEMGENIX continues to deliver elevated and sustained factor IX activity levels, can offer long-term and greater bleed protection compared to prophylactic treatment, can eliminate the need for routine factor IX prophylaxis, and maintains a favorable safety profile. Approved in 2022 by the U.S. Food and Drug Administration (FDA), HEMGENIX is the first gene therapy for the treatment of adults with hemophilia B who currently use factor IX prophylaxis therapy, or have current or historical life-threatening bleeding, or have repeated, serious spontaneous bleeding episodes. It is also the only approved gene therapy for hemophilia B that can treat adult patients with and without AAV5 neutralizing antibodies thereby providing the potential for a greater number of eligible patients to be treated."Hemophilia B can cause spontaneous bleeds into the joints, resulting in extreme pain and progressive, arthritis-like damage, which can lead to permanent physical debility," said Steven Pipe, MD, Professor of Pediatrics and Pathology, Laurence A
First patients treated with HEMGENIX® (etranacogene dezaparvovec) gene therapy for haemophilia B in Denmark. COPENHAGEN, DENMARK—21 January 2025 — CSL Behring Denmark today announced that the first Danish patients with haemophilia B were treated with the gene therapy HEMGENIX® (etranacogene dezaparvovec). HEMGENIX® is the first one-time gene therapy to be approved in Europe for the treatment of adults with severe and moderately severe haemophilia B, an inherited bleeding disorder caused by the lack of Factor IX (a protein needed to produce blood clots to stop bleeding). It is used in adults without a history of Factor IX inhibitors.1