Director, Packaging and Artwork Management

Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which cardiac muscle performance is compromised. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact myocardial muscle function and contractility.

Job purpose

We are seeking a Director of Packaging & Artwork Management to lead the strategy, systems, and execution of artwork lifecycle management. Reporting to the VP of External Manufacturing, this role will build inspection-ready, scalable, and fit-for-purpose artwork capabilities, with a strong emphasis on Global market requirements. This role is accountable for establishing end-to-end artwork management, including system selection and validation, intake and workflow design, lifecycle processes, and regulatory alignment. The leader will operate in a fast-paced, resource-constrained environment, balancing compliance, speed, and efficiency while supporting global commercialization.

Responsibilities

Artwork Strategy & Systems

• Define and implement a scalable global artwork strategy aligned to company growth.

• Lead selection, validation, and deployment of Artwork Management Systems (AMS), including:

• Ensure systems are GxP-compliant, right-sized, and integrated with Regulatory, Quality, and ERP platforms as appropriate.

Intake, Triage & Workflow Management

• Establish a centralized intake and prioritization model for artwork requests across products and markets.

• Implement governance and prioritization frameworks (launches, lifecycle changes, safety updates).

• Deploy tracking tools and dashboards to provide visibility into timelines, risks, and bottlenecks.

• Align artwork demand with regulatory submissions and manufacturing schedules.

Artwork Lifecycle Management

• Design and implement end-to-end processes (creation, review, approval, change control).

• Enable efficient cross-functional workflows that minimize cycle time while ensuring compliance.

• Establish version control, audit trails, and documentation to support inspection readiness.

• Oversee mock-ups and concept artwork for regulatory and internal use.

Safety & Time-Critical Labeling Updates

• Build lean, rapid-response processes for safety-driven labeling updates.

• Ensure accelerated execution while maintaining full compliance.

• Coordinate with Regulatory, Pharmacovigilance, and Manufacturing to support timely multi-country implementation.

Packaging & External Manufacturing Integration

• Partner with External Manufacturing and CMOs to ensure artwork is production-ready.

• Align artwork processes with packaging operations, supply timelines, and launch readiness.

• Provide oversight to artwork vendors and packaging partners to ensure quality and consistency.

Compliance, Quality & Continuous Improvement

• Establish and maintain GMP-compliant SOPs, policies, and workflows.

• Ensure all activities are inspection-ready and aligned with global expectations.

• Drive improvements in cycle time, right-first-time performance, and process simplicity.

Leadership & Performance Management

• Act as the artwork and labeling SME across Regulatory, Quality, Supply Chain, and Commercial.

• Define and track KPIs (cycle time, approval timelines, right-first-time, on-time delivery).

• Manage budget and vendors with a focus on cost-effective, scalable solutions.

Qualifications

Required Experience

• Bachelor’s degree preferred

• 10+ years in pharmaceutical packaging, labeling, and artwork management within a GxP environment

• Demonstrated experience building artwork intake, triage, and tracking processes in fast-paced environments

• Track record of success implementing end-to-end artwork lifecycle management

• Proven success in managing time-critical labeling and safety updates and selecting and deploying validated AMS platforms

Leadership Capabilities

• Proven ability to build scalable processes from the ground up

• Strong stakeholder management and decision-making skills

• Ability to simplify complexity and drive execution in resource-constrained settings

#LI-HYBRID

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) policy PRIOR 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.

Fraud Warning: How to Identify Impersonated Cytokinetics Job Postings and Offers

Recently, there have been fraudulent employment offers being sent to candidates on behalf of Cytokinetics. Please be advised that all legitimate offers from Cytokinetics will come directly from our official email domain (Cytokinetics.com) and will only be made after completing a formal interview process.

Here are some ways to check for authenticity:

• We do not conduct job interviews through non-standard text messaging applications

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• If you are unsure about the authenticity of an offer, or if you receive any suspicious communication, please contact us directly at [email protected]

Please visit our website at: www.cytokinetics.com

Cytokinetics is an Equal Opportunity Employer