Queensbury, New York

POSITION SUMMARY

The Manufacturing Assembler I will assist in the manufacture of disposable medical devices by fabricating, assembling, inspecting, labeling and packaging various medical device components.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

• Fabricate, assemble, inspect, label & package medical device components and products to consistently high quality standards as directed
• Strictly follow written procedures and maintain product and lot identification in accordance with company policies and good manufacturing practices
• Timely notify the supervisor when documentation or procedural errors are noticed and provide recommendations for continuous improvement to comply with FDA and other regulatory requirements
• Maintain accurate records for work performed
• Understand and utilize measurement instruments to verify work quality
• Perform project work, as assigned, for the Research and Development and Operations Departments
• Contribute to and maintain a professional and respectful work environment

To apply for this position, please send your resume to jobs@delcath.com.

Queensbury, New York

POSITION SUMMARY

The primary responsibilities of a Manufacturing Engineer include:

• supporting production by performing equipment troubleshooting, PMs on process equipment, and resolving day to day manufacturing concerns as they arise.
• supporting the business by developing and implementing process/product improvements, and resolving supplier change notifications. 

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. 

• Assist Product Development with researching and improving device design and/or quality utilizing new technology, products, materials, and equipment.
• Develop and implement manufacturing processes improvements, which foster lean manufacturing principles.
• Innovate and define technical solutions for research/development/design problems and lead efforts to realize the technical solutions.
• Assist with the research, design, prototype and test new products and processes.
• Complete complaint investigations and assist with documenting responses to customers
• Manage and implement supplier change notifications
• Complete root cause investigations associated with product/process non conformances and implement solid corrective actions to prevent reoccurrence.
• Lead and/or participate in project design reviews and development of use, design & process FMEA’s
• Write protocols, implement and lead process validation activities
• Write test methods and test method validation protocols/reports
• Perform/oversee test method validations and/or product testing
• Perform a wide variety of laboratory tasks and experiments to support the Company’s research and development goals such as maintain laboratory equipment and inventory levels for laboratory supplies, test product per protocols and test/inspection procedures
• Research/recommend, source & purchase Lab Equipment (from calipers to large test equipment (tensile tester, etc.)
• Perform equipment troubleshooting to maintain the required manufacturing output, as required
• Perform drafting/designer duties to create and revise fixtures, equipment, component and product drawings
• Assist other engineers in process development activities to support new product launches
• Perform PM’s and assist with calibrations on equipment, as required

To apply for this position, please send your resume to jobs@delcath.com.

Queensbury, New York

POSITION SUMMARY

The Quality Assurance Technician position is responsible for performing duties that help to organize and maintain an effective quality system.  The overall purpose of the position is to support the company goal of ensuring that Delcath is fully compliant to all applicable FDA and ISO regulations.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. 

• Responsible for monitoring and confirming manufacturing process activities
• Review/issue DHR’s to support Manufacturing operations
• Perform/review line clearance activities to support Manufacturing operations
• Responsible for reviewing manufacturing records and verifying data
• Perform in-process inspection of medical devices and device components
• Perform final product inspection and final release activities
• Responsible for organizing and performing Incoming Inspection duties
• Responsible for performing environmental monitoring testing, organizing data and creating reports
• Assist with supplier corrective actions and nonconforming material reports.
• Support and participate in quality investigations under supervision.
• Maintain accurate records in accordance with GMP/GDP requirements.
• Assist with verification and validation testing activities.
• Assist during internal and external audits by preparing records and responding to quality requests.
• Other duties as assigned.

To apply for this position, please send your resume to jobs@delcath.com.

Galway, Ireland

POSITION SUMMARY

Responsible for ensuring the effective establishment and maintenance of quality systems, and facility compliance to all applicable regulations.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

• Maintain effectiveness of the Quality Management System through the resolution of quality concerns and related issues as required.
• Provides support for quality and regulatory inspections.
• Generate procedures, specifications, and labels as required.
• Provides oversight for product releases: finished products, raw materials, packaging components, and labeling.
• Leads Quality Improvement projects.
• Participates/Supports Engineering Change projects
• Provides QA support to the Clinical trial supply system within the Galway facility in line with Clinical trial (EU) regulation 536/2014 supplemented by GMP regulation 2017/1569.
• Manage technical agreements with vendors and contractors.
• Conduct quality and regulatory investigations
• Maintain current knowledge base of all regulatory and quality assurance related changes within the industry.
• Participate in and conduct complaint investigations as required.
• Support the Internal Audit Program through the performance of audits as required
• Supports projects and tasks as assigned by the QA management
• In cooperation with the Qualified Person ensure the IMP authorisation once received is complied with and maintained current.
• Liaise with and keep the Qualified Person informed, as applicable in relation to all aspects of the quality management system that could have an impact on product quality safety and efficacy.

To apply for this position, please send your resume to jobs@delcath.com.

Galway, Ireland

POSITION SUMMARY

The Operations Engineer will be responsible for the overseeing all operations responsibilities for Delcath inventory and property in Europe and new markets outside of the United States. This role will also encompass product manufacture, clinical trial support, inventory rework, sales and marketing support, facilities engineering, building maintenance etc. in Galway, Ireland.  The Operations Engineer is a hands-on position that requires a flexible work schedule and dedicated commitment to completing tasks on time as well as within budget.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

• Production support in relation to EU clinical trial supply.
• Prepare purchase requisitions for inventory purchases and any other purchases as required from time to time
• Oversee logistics of inward and outward movements of inventory and other company property, including inspection, packaging, shipping, record retention and confirming delivery
• Maintain all internal logs in compliance with Delcath Statements of Practice
• Document and perform product kit manufacture for commercial and clinical operations in line with Delcath Statements of Practice and Quality department guidelines
• Document and perform rework of commercial medical device product (only) in line with Delcath Statements of Practice and Quality department guidelines
• Support activities to establish and maintain compliance with government and international regulatory requirements
• Work closely with Quality Department on projects that may be assigned from time to time
• Procure machinery and equipment to maintain facilities and support operations as required from time to time
• Work closely with tenants and landlord of Delcath facility as required on an ongoing basis to ensure all facility related matters are addressed in a professional and timely manner
• Work closely with vendors of Delcath facility as required on an ongoing basis to ensure all vendor related matters are addressed in a professional and timely manner
• Develop and implement maintenance schedules to ensure that equipment is effective and in efficient working order
• Develop and implement plans and programs to maintain a safe work environment in compliance with regulatory requirements
• Initiate, analyze, propose and implement cost reduction opportunities on a continual basis
• Support other functions within the EMEA team on an ongoing basis as required within the business (e.g. Sales & Marketing support)
• Support EMEA team locally in Galway and in the field with any Information Technology issues that may arise from time to time that can be addressed in Galway, as well as maintaining all IT services in place in EMEA (hardware, software, telecoms, broadband etc.)
• This job description is not all-inclusive; other activities should be expected and will be assigned as required by management

To apply for this position, please send your resume to jobs@delcath.com.

Remote

POSITION SUMMARY

This position is responsible for managing the HEPZATO KIT REMS program, including the REMS Coordinating Center, and for ensuring the preparation, compilation, distribution and filing of all documentation related to the function of the REMS Coordinating Center, contributing to the effective communication of all materials related to the operations of the REMS Coordinating Center and, in general, ensuring that the HEPZATO KIT REMS goals and goals related to the REMS Coordinating Center are met. This position is also responsible for assisting in the coordination of medical affairs projects at the discretion of the Senior Vice President of Clinical Development and Medical Affairs within a Project Team environment and further assisting in the preparation, compilation, distribution and filing of all documentation related to the function of the Project and Study Teams, contributing to the effective communication of all materials related to the operation of the Project and Study Teams and, in general, supporting the Project and Study Teams to ensure that the project goals are met.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

• Manages the HEPZATO KIT REMS program and the HEPZATO KIT REMS Coordinating Center, assures that allincoming forms are processed accurately, in a timely manner, and in accordance with relevant SOPs and FDA-agreed documents, assures that product shipments are approved by the REMS Coordinating Center inaccordance with relevant SOPs and FDA-agreed documents, communicates cross-functionally to ensure thatrelevant stakeholders are kept informed of REMS operation.

• Coordinates with Quality assurance to ensure productive audits, and responds to audit findings or other findingsof non-compliance in order to continually improve REMS operations

• Provides REMS training to internal Delcath team members and to external stakeholders as part of the REMS-required training program

• Coordinates the preparation and submission of regular REMS Assessments with other members of the ProjectTeam, ensuring that relevant information and activities are performed as outlined in FDA-agreed documents

• Coordinates documentation by working with the other members of the Project and Study Teams, assures that allcritical documentation pertaining to medical affairs is tracked, distributed, and filed according to StandardOperating Procedures (SOPs) and regulatory guidelines set forth by FDA; by attending Project and Study Teammeetings and managing critical documents such as agendas, slides, presentations, and minutes; by supportingand tracking development of key opinion leaders; by supporting and tracking development of safety data andpublications; ; by reviewing data and documents for submission to regulatory agencies; by supporting andtracking development of budget proposals and invoices for assigned projects, reviewing and updating systemwith invoices for approval, and by performing other tasks as requested by the Supervisor.

• Provides Medical Affairs Support by serving as a key resource to all members of the Project and Study Teams,both internal and external; by administering and tracking medical and clinical trial data for assigned Studies andby performing other tasks as requested by the Supervisor.

• Coordinates documentation of safety events. Assists in tracking, review and finalization of safety documents.

• Performs coordination with medical and clinical vendors by attending regularly scheduled study team meetings;following up on action items, as necessary; by providing feedback, as necessary to vendor staff; by escalatingissues, as appropriate; and by performing other tasks as requested by the Supervisor.

• Complies with Regulations by following all Company procedures to ensure compliance with FDA, GCP, and ICHregulations, federal and state laws, related statutes, and SOPs; and by advising the study team as necessary onmatters affecting project success.

• Executes all above mentioned task independently and with oversight from management. As well as;o

  • • Develops tracking and more efficient tools for medical affairs projects

    • Work closely with cross functional business groups to develop key essential documents and metricsneeded

    • Tracking, filing and maintenance of safety files

    • Propose business processes and operating processes to improve trial management

• Other tasks may be assigned at the discretion of the Supervisor.

To apply for this position, please send your resume to jobs@delcath.com.

Remote

POSITION SUMMARY

At Delcath Systems, marketing is about understanding people and building awareness of how our products and services can satisfy their needs. We’re looking for an experienced and versatile marketing manager who’s eager to do this and more. The ideal candidate is a proactive self-starter who brings expertise in marketing with a demonstrated ability to move audiences down funnel – by building and transforming awareness into qualified leads and transformative value. You will pair a sophisticated understanding of the uveal melanoma (UM) patient journey with an operational mindset, identifying the moments that matter to educate, motivate, and support patients and HCPs alike. You also will play a critical role in driving peer influence and education that impacts patient care in metastatic uveal melanoma (mUM). Additionally, the Marketing Manager serves as the subject matter expert on stakeholder engagement and is a productive influence on behalf of the commercial team across the enterprise. This role offers a unique opportunity to shape how HEPZATO KIT connects with the oncology community — blending scientific credibility with modern engagement strategies.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

• Serve as a marketing point of contact across functions to lead the Peer-to-Peer (P2P) marketing strategy for HEPZATO KIT, driving engagement and educational reach among ocular oncologists, medical oncologists, associated advanced practice practitioners (APPs), and related patient advocacy groups.
• Leverage insights to build and execute strategy related to mUM for educational engagement with market stakeholders (HCPs, Patient Advocacy) and drive value to the mUM treatment journey.
• Prioritize patient engagement touchpoints through designed and scaled programs that empower and enable patients—from disease awareness and education to advocacy.
• Collaborate with Analytics to inform brand positioning, measure behavioral data, reach, engagement, impact of awareness and educational campaigns, and identify new opportunities to deliver value to the treatment mUM experience.
• Oversee development of content and messaging across channels, ensuring clarity, consistency, and differentiation of HEPZATO KIT.
• Oversee creation and dissemination of speaker decks, symposium content, and congress booth experiences, ensuring alignment with brand strategy.
• Lead booth and additional sponsorship and advertising content including peer interaction strategies at oncology congresses and symposiums.

To apply for this position, please send your resume to jobs@delcath.com.

Remote

POSITION SUMMARY

As the Strategic Marketing Manager at Delcath, you will partner with internal stakeholders to own both Market Access and Brand/HCP marketing strategy and execution for HEPZATO KIT through creation of compelling and customized value propositions which include economic and clinical arguments and evidence for payers, HCPs, and budget-holders. You will collaborate with Sales, Marketing, Healthcare Systems, and Market Access team (MAx) to improve and maintain reimbursement tools and content, drive pull-through of payor coverage strategies, provide support for new business development, and support reimbursement training across the sales franchise. This is a true hybrid role with high-visibility, high-impact influence that combines payer/value work with classic oncology brand marketing and HCP engagement.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

Brand Marketing

• Develop and execute brand plans, positioning, messaging platforms, and campaign strategy for HEPZATO KIT focused on medical oncology, interventional oncology and ocular oncology audiences.
• Create and manage promotional materials and programs including detail aids, brochures, flashcards, banner campaigns, website content, and non-personal promotion.
• Translate complex clinical and real-world data into clear, compelling, and memorable messages for HCPs
• Lead brand-related market research (HCP and patient) research, competitive intelligence, and message testing
• Collaborate with Patient Services on patient support program marketing and collateral (as needed).

Market Access (MAx) Marketing

• Collaborate with clients to develop annual MAx brand plans, including strategic initiatives and supporting tactics.
• Drive and contribute directly to the creation of high-impact marketing materials (e.g., payer value propositions, pre-approval information exchange (PIE) decks, banner ads, brochures, flashcards, formulary kits, patient support collateral)
• Conduct ongoing payer landscape assessments, PSS benchmarking, and health economic modeling to inform value propositions, pricing, and coverage strategies.
• Oversee and participate in the medical, legal, regulatory (MLR) submission and review process for all collateral material as necessary.
• Customize technical data into simple compelling messages.

To apply for this position, please send your resume to jobs@delcath.com.

Europe

POSITION SUMMARY

We’re seeking a Clinical Science Liaison (CSL) – Europe to partner with investigators and research sites, ensuring the success of ongoing trials while identifying new partners across the region. This role is perfect for someone passionate about advancing science through site engagement and hands-on clinical support.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

Strategic Objectives

• Strengthen and expand relationships with clinical investigators, site staff, and research networks.
• Act as a scientific resource for trial sites to ensure alignment with study protocols.
• Proactively identify and recommend new clinical sites that align with strategic trial expansion goals.
• Communicate scientific and operational insights from sites to inform clinical development strategies.
• Provide clinical insights to optimize patient recruitment and retention.

Operational Objectives

• Assist with feasibility assessments and documentation required for onboarding new clinical sites.
• Collaborate with cross-functional teams (Clinical Operations, Medical Affairs, Regulatory) to resolve site-level issues and ensure trial timelines are met.
• Attendance at scientific and medical conferences.
• Must be able to travel, at least twice a month, to clinical sites for in-person meetings.

To apply for this position, please send your resume to jobs@delcath.com.

Remote

POSITION SUMMARY

We are seeking a highly motivated medical science liaison to join our Medical Affairs team at Delcath Systems. The USA field based “Medical Science Liaison” is responsible for supporting the safe and effective use of, HEPZATO KIT, communicating complex medical and scientific information to healthcare professionals and communicating field medical intelligence/insights to internal stakeholders. The MSL has internal and external training responsible for all Delcath oncology therapies. The MSL has an assigned territory autonomously managing, developing and growing medical activities/initiatives aimed at achieving key medical objectives.

The MSL must live within the assigned territory and have access to good/exceptional air service.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

1. External Engagement/Insight Gathering
2. Data Dissemination
3. Data Generation
4. Education

Therapy Training and Education to guide the safe and effective use of HEPZATO KIT

• Proactively engage HCPs providing product and procedural overview and training of HEPZATO KIT.
• As a subject matter expert, teach medical education and internal training courses.
• Provide product and disease-state educational/training support to the Delcath Commercial and R&D functions related to technical, medical and scientific information.

Medical Support

• Build, maintain and manage effective professional peer-peer relationships with medical oncology and the HEPZATO KIT procedure team members (interventional radiology, anesthesiology, perfusion) in alignment with commercial activities and strategies within a given territory
• Engage thought leaders engaging in bi-directional exchange to gain insights on the medical and scientific barriers that could influence patient outcomes and opportunities for education
• Disseminate relevant and timely clinical data in proactive and reactive manner, and inform HCPs about key evidence gaps
• Focus on new data generation involving ongoing research with IITs and RWE
• Teach the clinical evidence story linking the totality of evidence in a non-biased manner
• Execute on engagement, data generation, and data dissemination plans communicating technical and to support the HEPZATO KIT and/or new indications
• Create a territory plan aligned with field commercial colleagues for efficient execution of the medical affairs plans in a respective territory
• Provide medical and scientific support for Thought Leaders speaking on Delcath products at medical meetings and congresses. 
• Investigate and gather field medical intelligence/insights that might affect therapy safety/efficacy, Clinical/R&D strategies and competitive activities. Create strategies to gain insights from a diverse set of stakeholders.
• Communicate knowledge in a simple, coherent and informative manner to internal stakeholders
• Identify clinical insights and knowledge gaps and be able to articulate the impact and magnitude of the findings
• Provides medical/scientific congress support communicating accurate information with timely follow up
• Attends key sessions and communicates knowledge in a simple, coherent and informative manner to internal stakeholders. Develops and executes on Thought Leader engagement plan at the congress
• Provide quarterly updates to senior leadership on the progress and tracking of and medical/scientific insights related to activities and strategies to support the external engagement
• Applying exceptional literature searching and curator skills directly addressing medical information requests from HCPs 
• Provide thoughtful and medically sound assessments in a timely manner
• Utilize medical information to appropriately build Thought Leader relationships and deliver medical insights to the business.

Data Generation Support

• Through scientific exchange, discover novel investigator-initiated trials (IIT) ideas. Clearly articulate Delcath’ s strategic interest and fully understand how a concept fits within the strategy. Fully appreciate novel ideas that could significantly impact patient care. Support Investigator Initiated research/study program by discovering and championing innovative ideas, facilitate study start up and provide ongoing consultation.
• Provide quarterly updates to senior leadership on study progress, tracking, and milestones for all data generation activities
• Assist Delcath Clinical Development department with company sponsored clinical trials focusing on clinical trial site identification, site initiation, site protocol education, and ongoing support. Identify key issues that are accelerating or inhibiting patient recruitment, quality data collection or patient retention. Recommend research sites that can perform well delivering patient enrollment and quality data. Support principal investigator and provide up to date information that may improve patient recruitment and/or data quality. Provide medical insights and updates on key findings affecting the study performance.

To apply for this position, please send your resume to jobs@delcath.com.

Queensbury, NY

POSITION SUMMARY

The Quality Engineer is responsible for supporting the effective establishment and maintenance of the Delcath Quality System and ensuring that the facility is fully compliant to all applicable FDA, ISO regulations and the Medical Device Directives/Regulations.

The Quality Engineer provides QA support for the company by working with the Quality Assurance Manager to assure proper GMP compliance within Delcath Systems.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

• Maintain effectiveness of the Quality Management System through the resolution of quality concerns and related issues.
• Develop and maintain Quality System procedures, including those governing quality control processes and product specifications
• Lead continuous improvements projects. • Participate on new product design teams as the design assurance engineer.
• Implement and maintain risk management activities throughout the product lifecycle, including risk analysis (UFMEA, DFMEA, PFMEA) and control measures.
• Ensure proper creation, maintenance, and review of Technical Files and Design History Files (DHF) in compliance with regulatory requirements and design control processes.
• Perform and support design verification/validation, process validation, software validation and test method validation. • Lead root cause investigations to identify issues and drive effective corrective actions.
• Conduct non-conformance activities, including containment, investigation, and disposition.
• Support the Corrective Action and Preventive Action Program.
• Support the Supplier Quality Program, including supplier evaluations, supplier corrective actions, and on-site quality audits.
• Conduct calibration investigation failures on equipment.
• Conduct customer complaint investigations.
• Support the Internal Audit Program through the performance of audits.
• Perform data and statistical trend analysis and support quality monitoring and metrics.
• Provides oversight for product releases, including finished products, raw materials, packaging components, and labeling.

To apply for this position, please send your resume to jobs@delcath.com.

Remote

POSITION SUMMARY

We’re seeking a Clinical Science Liaison (CSL) – Europe to partner with investigators and research sites, ensuring the success of ongoing trials while identifying new clinical partners across the region. This role is perfect for someone passionate about advancing science through strong site engagement and hands-on clinical support. 

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

Strategic Objectives  

• Strengthen and expand relationships with clinical investigators, site staff, and research networks.  

• Act as a scientific resource for trial sites to ensure alignment with study protocols.  

• Proactively identify and recommend new clinical sites that align with strategic trial expansion goals. 

• Communicate scientific and operational insights from sites to inform clinical development strategy. 

• Provide clinical insights to optimize patient recruitment and retention. 

Operational Objectives  

• Assist with feasibility assessments and documentation required for onboarding new clinical sites.  

• Collaborate with cross-functional teams (Clinical Operations, Medical Affairs, Regulatory) to resolve site-level issues and ensure trial timelines are met. 

• Attendance at scientific and medical conferences.
• Must be able to travel to clinical sites for in person meetings.

• Maintain accurate and timely records of site interactions, insights, and feedback. 

To apply for this position, please send your resume to jobs@delcath.com.