Associate Director, Packaging & Artwork Management

Cytokinetics; Ireland; Hybrid; EUR 90,000 - 120,000; Full time

Job summary

Cytokinetics is a specialty cardiovascular biopharmaceutical company focused on pioneering muscle biology to treat heart diseases. We seek an Associate Director, Packaging & Artwork Management to lead global artwork lifecycle execution and continuous improvement, coordinating with Regulatory Affairs, Supply Chain, and CMOs.

The role requires extensive experience in artwork management, regulatory compliance, and packaging operations in a GxP setting.

Qualifications

• Primary degree in related field or equivalent.
• 8+ years in pharmaceutical packaging, labeling, and artwork management within a GxP environment.
• Strong understanding of regulatory requirements and industry standards governing artwork, labelling, and packaging of pharmaceutical products.
• Strong understanding of supply chain requirements for implementation of pharmaceutical artwork and packaging components.
• Strong understanding of external packaging operations and print procurement processes supporting development and production of pharmaceutical artwork and packaging components.
• Proven success in supporting the implementation of end-to-end artwork lifecycle management systems is preferred.

Responsibilities

• Serve as the primary point of contact for all artwork-related queries and issues.
• Manage day-to-day artwork management activities and maintain the artwork database.
• Coordinate artwork change requests and drive robust procedures/workflows.
• Support product launches, line extensions, market expansions, and maintenance activities through effective artwork coordination.
• Liaise with Regulatory Affairs on artwork approvals and change requests.
• Oversee mock-ups and concept artwork for regulatory/internal use.
• Coordinate with stakeholders to meet component implementation timelines.
• Communicate upcoming artwork changes to CMOs to reduce write-off costs.
• Escalate delays or risks to stakeholders as required.
• Assist in developing and delivering artwork-related training.
• Support validation and implementation of Artwork Management Systems (AMS).
• Use automated proofreading tools to improve accuracy and efficiency.
• Drive cycle time improvements and right-first-time performance.

Skills

Artwork management

Regulatory knowledge

Supply chain coordination

Packaging operations

Print procurement

AMS implementation

Automated proofreading

Project reporting

Education

Bachelor's degree in related field

Tools

Artwork Management System (AMS)

Regulatory databases

Job description

Cytokineticsis a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction.

We are seeking an Associate Director, Packaging & Artwork Management to support the execution and continuous improvement of artwork lifecycle management across global commercial markets. Reporting to the Director, Packaging & Artwork Management, this role will lead day-to-day artwork management activities between market partners, Regulatory Affairs, Supply Chain, External Manufacturing, and Contract Manufacturing Organisations (CMOs), ensuring the timely and compliant delivery of packaging artwork. The successful candidate will have experience in artwork management and coordination, with an understanding of regulatory, supply chain, and commercial requirements. Knowledge of both manual artwork processes and artwork management systems is highly desirable. This role will operate in a fast-paced, resource-constrained environment, balancing compliance, speed, and efficiency while supporting global commercialisation.

Responsibilities:

• Primary point of contact for all artwork-related queries and issues.
• Perform day-to-day artwork management activities.
• Manage artwork change requests and maintain the artwork database.
• Build and maintain robust procedures and workflows.
• Support product launches, line extensions, market expansions, and product maintenance activities through effective artwork coordination.
• Liaise and coordinate with Regulatory Affairs regarding artwork approvals and artwork change requests.
• Oversee mock-ups and concept artwork for regulatory and internal use.
• Work closely with stakeholders to achieve component Implementation timelines.
• Communicate upcoming artwork changes to CMOs in a timely manner to minmise printed component write-off costs.
• Escalate artwork-related delays, risks, or issues to stakeholders as required.
• Support the development and delivery of artwork-related training to internal and external stakeholders.
• Support the validation and implementation of Artwork Management Systems (AMS).
• Utilise automated proofreading tools to improve artwork accuracy and efficiency.
• Drive improvements in cycle time, right-first-time performance, and process simplicity.
• Prepare and communicate artwork status reports, project dashboards, and KPI performance updates to stakeholders and leadership.
• Travel (up to 15%) may be required.

Qualifications - Required Experience:

• Primary degree in related field or equivalent.
• 8+ years in pharmaceutical packaging, labeling, and artwork management within a GxP environment.
• Strong understanding of regulatory requirements and industry standards governing the artwork, labelling, and packaging of pharmaceutical products.
• Strong understanding of supply chain requirements associated with the implementation of pharmaceutical artwork and packaging components.
• Strong understanding of external packaging operations and print procurement processes supporting the development and production of pharmaceutical artwork and packaging components.
• Proven success in supporting the implementation of end-to-end artwork lifecycle management systems is preferred.

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Pay Range:

Our employees come from different backgrounds, and we celebrate those differences. We are looking for the best candidates for our open roles, but do not expect applicants to meet every qualification in order to be considered. If you are excited about what you could accomplish at Cytokinetics and believe you can add value to our team, we would love to hear from you.

Please review our General Data Protection Regulation (GDPR) policyPRIOR to applying.

Our passion is anchored in robust scientific thinking, grounded in integrity and critical thinking. We keep the patient front and center in all we do - all actions and decisions are in service of the patient and their caregivers. We champion integrity, ethics, doing the right thing, and being our best selves.

Please visit our website at:www.cytokinetics.com

Cytokinetics is an Equal Opportunity Employer