PTC Therapeutics is a global commercial biopharmaceutical company. For over 25 years our team has been deeply committed to a unified purpose: Extending life's moments for children and adults living with a rare disease.
At PTC, we cultivate an inclusive culture where everyone feels valued, respected, and empowered. We welcome candidates from all backgrounds to join our team, fostering a strong sense of belonging.
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The Senior Artwork Specialist manages artwork updates and ensures that any associated regulatory implementation deadlines and supply requirements are met. He/she liaises with all internal and external parties involved in the process (CMO, QA, Legal, Commercial, Regulatory Affairs, Artwork Studio) to ensure clear communication of project goals and timelines thus preventing re-work and excessive on-cost. He/she will manage their own project plans to ensure that artworks are created on time and in full, and all projects are delivered to market on time.
He/she manages the communication and escalation of day-to-day activities and projects to the relevant parties where delays are encountered that have a potential impact to compliance, supply, and/or project timings.
Job Description:
PRIMARY DUTIES/ RESPONSIBILITIES
Artwork Coordination
* Initiate artwork changes in PTC's artwork management system (GLAMS) based on notifications of regulatory approval and/or project schedules
* Coordinate artwork changes through input, creation/update and approval with relevant internal and external functions (CMO, QA, Legal, Commercial, Regulatory Affairs, Artwork Studio)
* Coordinate requests for mock-ups to support submissions to regulatory authorities
* Coordinate, review and approve the creation and update of manufacturing site documents related to packaging operations (e.g. BOMs, packaging configurations, technical drawings, etc.)
* Manage the implementation timelines for artwork changes
* Agree implementation requirements with RA
* Plan and manage projects around the agreed implementation requirements and manufacturing planning schedules.
* Liaise with all stakeholders to ensure implementation requirements are communicated clearly
* Ensure artworks are approved and released on time to meet implementation requirements
* Coordinates artwork status & performance reports/metrics
Packaging, New Product Introduction, Product lifecycle management
* Provide input into the packaging process and packaging process validation at CMOs
* Manage and provide input to packaging configuration changes
* Define and manage artwork and packaging requirements for new commercial SKUs
* Coordinate the introduction of new commercial SKUs at CMOs
Communication
* Facilitates cross-functional communication within the project team
* Coordinates appropriate project status communications within and outside the project team
* Anticipates and seeks resolution of issues
Quality, Compliance & Continuous Improvement
* Manages quality records (Change control, deviation, CAPA) on PTC's QMS system (Veeva)
* Ensure on-time closure of quality records
* Proactively engage within department to improve and maintain compliance and audit-ready status.
* Work cross-functionally to identify process improvement areas.
* Ensure procedures are compliant and followed
* Prepare and update documentation/procedures, as required, for compliance and continuous improvement projects.
* Actively participate in system upgrade/process improvement projects.
* Performs other tasks and assignments as needed and specified by management.
KNOWLEDGE/SKILLS/ABILITIES REQUIRED:
* A relevant science/engineering bachelor's degree preferred and/or equivalent work experience.
* A minimum of 2 years artwork coordination experience, preferably in the pharmaceutical industry.
* Technical/hands-on experience with pharmaceutical packaging process and packaging material development desirable
* Detail and technical oriented, focused on accuracy.
* Analytical thinker with excellent problem-solving skills
* Intellectual curiosity – willing to learn, as well as to suggest and try new ideas.
* Takes ownership and accountability for activities.
* Positive and proactive approach to business tasks.
* Excellent verbal and written communication and skills.
* Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
* Excellent planning, organization and time management skills including the ability to support and prioritise multiple projects.
* Sense of urgency – responding to issues and opportunities in a timely manner.
* Ability to manage multiple artwork change projects whilst ensuring compliance and supply-to-market requirements are always met.
* Experience of working in accordance with quality standards, e.g. GMP.
* Experience of using a quality management system.
* Demonstrated ability to establish and maintain effective working relationships with internal team members and external vendors.
* Ability to prioritise decisions and activities to ensure efficient use of resources and address critical issues impacting the business.
* Proficiency with Microsoft Office.
EEO Statement:
PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.