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Senior Packaging Specialist

2 months ago

Cambridge, United States Alnylam Full time

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This role is considered Hybrid.

Summary of Key Responsibilities

  • Managing CMO management through maintenance of positive relationships
  • Next point of contact on escalation and decision path
  • Responsible for packing activities are executed for continuous flow of finished goods to the 3PLs
  • Responsible for all necessary products, components and documentation are in place to support the packaging & labeling plan.
  • Coordinate SAP S4Hana activities: inbound supply, good receipt, STO, PO creation and inventory reconciliation.
  • Supporting associated costs and approve payments on vendor invoices
  • Managing, monitoring and reporting Inventory levels, PO planning and KPI reporting.
  • Supporting and coordination serialization service and technical related activities
  • Responsible for SMD completion as needed in collaboration with CMO team for all FG commercial packs
  • Responsible for coordinating serialization tasks: invoicing, administrative activities and reviewing documentation
  • CoordinateS4Hanaactivities: inbound supply, good receipt, STO, PO creation and inventory reconciliation.
  • Coordinate associated costs and payments on vendor invoices
  • Managing and reporting Inventory levels, PO planning and KPI reporting
  • Work with suppliers importing goods to ensure correctness of import documents and support logistical shipments from testing laboratory and external warehousing to CMOs
  • Ability to confidently address upper management with accurate, timely status updates on serialization and on related packing activities
  • Driving continuous improvement initiatives to optimize the packing & operations processes and procedures (e.g. SOP's, WI & FRMs, services, efficiency, costs)
  • Areas of focus will include project management, support of commercial technology transfers, change management, data management, and review of supplier KPI tracking tools.
  • Extensive collaboration with internal customers in a matrix environment is required.

Qualifications & Competencies

  • Strong interpersonal skills, ability to engage with stakeholders at all levels across the organization
  • Effective verbal and written communication skills with internal and external customers
  • Customer focused and high level of integrity. Open and transparent
  • Solid understanding of GMP Manufacturing and Quality principles across clinical and commercial products is required
  • Knowledge of pharmaceutical secondary packaging operations and medical device is desirable
  • Experience with parenteral products (vials, prefilled syringes and injection aides) is desirable
  • Knowledge of product lifecycle management requirements is desirable
  • High level understanding of Pharmaceutical or Biologics industry combined with new product introduction
  • Entrepreneurial mindset is preferred
  • Good understanding of the various elements of Manufacturing and Supply Chain
  • Knowledge in Import/Export related activities and Trade compliance is desired
  • Ability to work in a multicultural and fast changing business environment
  • Pro-active with and problems solving mentality
  • Able to follow up on feedback to ensure positive outcomes
  • Fluent in English, an additional language would be preferred
  • Strong planning, organizational and analytical skills
  • Knowledge on serialization regulations and impacts
  • Proficient in interpreting/assessing technical documentation (e.g. EPCIS GS1 standards, vendor configuration documents) and in maintaining related internal documentation (User Requirements, Master Data, Configuration Specifications)
  • Strong user knowledge of SAP S4Hana

About Alnylam:Alnylam Pharmaceuticals (Nasdaq: ALNY) has led the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare and more prevalent diseases. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach to treating diseases at their genetic source by "interfering" with mRNA that cause or contribute to disease. Since our founding in 2002, Alnylam has led the RNAi Revolution and continues to turn scientific possibility into reality.

Our culture:Our people-first culture is guided by our core values: fiercely innovative, open culture, purposeful urgency, passion for excellence, and commitment to people, and these values influence how we work and the business decisions we make. Thanks to feedback from our employees over the years, we've been fortunate to be named a top employer around the world. Alnylam is extremely proud to have been recognized as one of Science Magazine's Top Biopharma Employers, one of America's Most Responsible Companies for 2024 by Newsweek, a Fast Company Best Workplace for Innovators, and a Great Place to Work in Canada, France, Italy, Spain, Switzerland, and UK - among others.

At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. We are dedicated to building an environment where employees can feel that they belong, can bring their authentic selves to work, and achieve to their full potential. By empowering employees to embrace their unique differences at work, our business grows stronger with advanced and original thinking, allowing us to bring groundbreaking medicines to patients.

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