Senior Specialist, Artwork Management, Supply Chain

The Senior Artwork Specialist of Artwork Management will report to the Associate Director of Artwork Management within the Supply Chain Team. In this role, the primary responsibility for the Senior Artwork Specialist will be to develop and execute the artwork management process for printed packaging components used in Alnylam drug product packaging operations. This work may be related to New Product Launches, line extensions, new country introductions, revisions and lifecycle management. This role will not be product specific; this role will be to support all Alnylam markets for all potential programs. This role will ensure adherence to stringent quality standards while providing exemplary service, within the established readiness timelines. This entails establishing necessary specifications and overseeing the business processes to ensure compliance with all relevant GxP regulations while working cross funciationally with other enabling functions.

This Global role will include working on projects to improve existing processes/procedures to ensure artwork is created in an efficient and compliant GxP manner. Additionally, this role may also sit on country launch teams as appropriate to support the continued expansion of Alnylam products. .

This position is Hybrid and will be primarily located in Cambridge, MA.

Key Responsibilities

• Accountable and responsible for executing global artwork management process and partnering with Regulatory, Quality Assurance, IT, Commercial, Supply Chain and external stakeholders to ensure that their business requirements are understood and that artwork services are delivered to agreed standards to meet those needs.
• Ensure required artworks for new product launches, line extensions, country extensions, labeling and safety updates, technical changes and other business drivers are delivered in an accurate and timely manner ahead of set implementation dates.
• Responsible and accountable for process execution and adherence to required completion dates. Working directly with 3rd party artwork provider, print vendor and Contract Manufacturing Operations (CMO) on publishing new/revised artwork and technical drawings/guides.
• Expedite and monitor actions required by other functions until completion.
• Ensure artwork operations are appropriately represented on cross-functional project teams.
• Review and manage artwork action items in the GxP system/process and ensure all items are closed out in an appropriate fashion.
• Support the AD with the management of external artwork service providers, including proof reading process where applicable, against agreed targets of customer service and reliability, including ongoing continuous improvement.
• Execute on the ongoing strategy for the provision of packaging artwork services which meets the business needs of Regulatory, Quality Assurance, Commercial, Operations, CMOs and Pack Label vendor and to contract with these business units to deliver services to meet these needs.
• Collaborate and agree with key customers, the correct metrics (KPI) against which the performance of the Artwork management process will be measured. Execute the KPI metrics on an ongoing basis to be used in a monthly reviews with Tech Ops and Quality Leadership. Information on KPIs would include artwork recall, number of amends, schedule adherence and financial metrics.
• Collaborate with the AD of Artwork Management on the maintenance of medium to long term forecasts and associated financial plans for workload and subsequent resources, ensuring operations, processes and supporting IT systems are maintained and developed in a state of continual compliance.
• Support all activities associated with the build out of an e solution for artwork management system related to GxP label development and artwork services.

Qualifications

• Bachelor's or advanced degree in Engineering, Sciences, or related field.
• 2-7 years of experience in the biopharmaceutical industry, with a strong understanding of GMP requirements, including significant experience in supporting and managing artwork and packaging design, specifications, and lifecycle management.
• Proficiency in artwork management systems and integration, with preference given to experience with GLAMS.
• Expertise across a broad spectrum of business processes relevant to artwork and labeling.
• In-depth knowledge of the regulatory environment and requirements pertaining to both artwork and business process/IT compliance.
• Understanding of the complexity of a global business with some international experience
• Must have the ability to handle complex problems and have excellent analytical and investigational skills as well as sound, timely decision-making abilities.
• Ability to manage multiple competing projects, programs and priorities.
• Focus on operational excellence, standardization, innovation, and compliance.
• Excellent written and verbal communication.
• Self-driven and able to act independently and on own responsibility.
• Team player and adaptable to a dynamic environment.

U.S. Pay Range

$97,100.00 - $131,300.00

The pay range reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on a number of factors including, but not limited to, relevant experience, skills, and education. This role is eligible for an annual short-term incentive award (e.g., bonus or sales incentive) and an annual long-term incentive award (e.g., equity).

Alnylam's robust Total Rewards package is designed to support your overall health and well-being. We offer comprehensive benefits including medical, dental, and vision coverage, life and disability insurance, a lifestyle reimbursement program, flexible spending and health savings accounts and a 401(k)with a generous company match. Eligible employees enjoy paid time off, wellness days, holidays, and two company-wide recharge breaks. We also offer generous family resources and leave. Our commitment to your well-being reflects our belief that caring for our people fuels the impact we create together.

Learn more about these and additional benefits offered by Alnylam by visiting the Benefits section of the Careers website: https://www.alnylam.com/careers

AboutAlnylam

We are the leader in RNAi therapeutics- a revolutionaryapproach with the potential to transform the lives of people with rare and common diseases. Built on Nobel Prize-winning science, Alnylam has delivered the breakthroughs that made RNAi therapeutics possibleand are just at the beginning of what's possible. Our deep pipeline, late-stage programs, and bold vision reflect our core values: fierce innovation, passion for excellence, purposeful urgency, open culture and commitment to people. We're proud to be a globally recognized top employer, wherean authentic, inclusive culture and breakthrough thinkingfuel one another.

At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. Qualified applicants will receive consideration for employment without regard to their sex, gender or gender identity, sexual orientation, race, color, ethnicity, national origin, ancestry, citizenship, religion, creed, physical or mental disability, pregnancy status or related conditions, genetic information, veteran or military status, marital or familial status, political affiliation, age, or any other factor protected by federal, state, or local law. Alnylam is an E-Verify Employer.