Seagen

Specialist, Shipping Validation -- Documentation & Logistics

Description

Summary

This position supports the Senior Manager, Distribution and Shipping Validation with supply chain and logistics Shipping Validation activity. Tactical responsibilities may include the development and execution of shipping risk assessments, design tests, shipping validation protocols and summary reports. The role will include data gathering, research and document management. Expected to have knowledge across many functional areas and resources related to supply chain and logistics. Works closely with internal and external resources to optimize shipping validation.

Principal Responsibilities:

• The Specialist, Shipping Validation will support the Senior Manager, Distribution and Shipping Validation with shipping validation activity that includes data and information gathering, technical writing and document management
• Technical writing may include any of the following:
• Developing and managing workflow of shipping risk assessments, design tests, shipping validation protocols and summary reports
• Developing and managing workflow of packaging configuration documents based on current or new procedures
• Developing and managing workflow of vendor consignment protocols for component and product supply chain segments
• Revising and managing workflow of general shipping documents, procedures, work instructions, etc.
• Gathering data and/or collecting information, documents, etc. to be used in shipping risk assessments, protocols, reports, periodic reviews, etc.
• Scope of work will include current Seagen products, such as additions or changes to existing supply chain segments and products in development
• Collaborators will include Global Logistics and Distribution team members, other team members within the Global Supply Operations organization, Quality Assurance, CMC Project Management, etc. as well as vendors and partners at contract manufacturing organizations
• Collect product and component logistical requirements and present in a consistent manner that can be synthesized into GMP (Good Manufacturing Practice) documents and the company document management system
• Work with approved contractors to design and validate shipping systems for components of the Seagen supply chain
• Assess worst case scenarios, develop risk responses, and design validation studies in association with Quality Operations group
• Work within a highly regulated environment that includes following industry, company or department policies, procedures, or practices
• Tasks may include problem-solving and tackling significant and complex issues that involve in-depth evaluation and summarization

Required Qualifications:

• Requires BS/BA degree
• Excellent verbal and technical written communication, interpersonal, and negotiation skills are essential
• 5+ years of industry experience with 3+ year of logistics/distribution experience included and/or 3+ years pharma/biotech experience required
• Experience working with a document management system
• Experience working with an integrated ERP system. (SAP, Oracle, etc.)
• Continuously maintains industry leading knowledge by attending seminars, conferences, etc. on a yearly basis
• Must be able to travel internationally and hold a valid passport
• Travel 10-25%

Preferred Qualifications:

• Three to five years of experience in a biotech supply chain role that included authoring or document coordination of standard operating procedures, work instructions and/or other business or technical documents
• Familiarity with logistics operations, transportation systems and supply chain concepts
• Familiarity with various computer-based platforms and ability to integrate media from various platforms into cohesive format, e.g. collection of content, tables, diagrams, photos, etc. into documents
• Ability to work independently while meeting deadlines and able to pivot if project priorities shift
• Project management experience

As the leading employer in our industry in the Pacific Northwest, Seagen is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seagen, please visit www.seagen.com.

Seagen is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law.

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Seagen

Seagen is an Equal Opportunity Employer

Submitted: 01/08/2021