Seagen

Director Materials Management - Launch Pad

Technical Operations & Process Sciences - Bothell, United States

Seagen is a global, multi-product biotechnology company dedicated to developing and commercializing transformative cancer medicines. As the industry leader in antibody-drug conjugate (ADC) technology, we pioneered a new generation in the science of harnessing antibodies to deliver cell-killing agents directly to cancer cells. Seagen’s dedication to improving the lives of cancer patients goes beyond science, and we believe that every employee has a role in contributing to this mission. By working together with a shared dedication and diverse perspectives, we are able to reach our full potential and make a real difference in the world. Seagen is a fast-growing company and has an abundance of opportunities available for you to grow your career. Put your passion to work at Seagen and join us!

Summary

Seagen is seeking a highly motivated Director, Materials Management that desires an opportunity to significantly contribute to the development and commercialization of transformative cancer therapies. The initial focus of this position will be to actively participate and contribute to the design, build, and operational startup of Seagen’s new clinical and commercial biologics manufacturing facility. This position will also provide strong leadership and technical expertise in inventory management control, bill of materials management, demand planning, GMP warehousing operations, and productive collaboration with partner organizations.

Principal Responsibilities:

• Actively participate and contribute to the facility design and operational startup, including, but not limited to, conceptual design, basic design, and detailed design packages and components, process equipment commissioning and qualification, and facility operational readiness activities.
• Build and lead a warehouse operations team, provide strong leadership and technical expertise to demand planners and warehousing staff, and productivity collaborate with partner organizations.
• Implement, qualify, and maintain a cGMP compliant inventory management control system (enterprise resource planning), including master data set up for capacity planning, plan to deliver, master production schedule, bill of materials creations, demand planning and procurement tracking.
• Oversee and manage all aspects of raw materials demand/requisitions, receipt, storage, quarantine/release, distribution, shipping, and physical inventory and reconciliation.
• Develop and maintain all GMP documents for materials control program, including but not limited to SOPs for receipt; quarantine & release; weigh, dispense, and kitting; shipping, demand planning, BOM creation, and equipment use logs.
• Qualification of ambient warehouse and cold-room storage.
• Warehouse set up and operations, including but not limited to, lean risk-based business and quality processes (e.g., ABC-risk based safety stock, Dock-to-Stock, and Materials Classifications); Kanban set up and inventory management; picking, put-aways, cycle counting, storage controls, alarm management, reject/hold cage, and business continuity.
• Ensure staff GMP training compliance.
• Provide technical expertise to lead and close investigations, non-conformances, and corrective actions.
• Participate in and support internal and regulatory authority facility audits and site inspections.
• Assist in the generation, tracking, and adherence to Capex and Opex budgets.
• Provide strong leadership, guide, and mentor staff to ensure productive and collaborative organizational performance and individual career growth.
• Productively partner with Product Supply, QA, QC, F&E, MSAT, EH&S, and Finance functions.

Required Qualifications:

• Bachelor’s degree and 15+ years of managerial and operational experience in high volume distribution environment.
• Extensive knowledge of GdPs, cGMPs, and regulatory requirements including 21 CFR Parts 11, 210 and 211, and ICH Q7.
• Extensive knowledge of OSHA, DOT, HAZMAT and FDA regulations.
• Exceptional leadership skills to thoughtfully guide teams and individuals.
• Significant contributor to multi-disciplinary teams at the functional level; mentors and provides technical leadership to individuals within the team.
• Key competencies in verbal and written communication; attention to detail; data collection, management, and analysis; judgement and decision making; and teamwork.
• Capacity to develop solutions for technical issues of difficult scope.

Preferred Qualifications:

• Fundamental understanding and basic operation of MES (e.g., PAS/X) systems
• Experience in helping to build and maintain a Mfg. Operations infrastructure in a fast-paced and growing company
• Experience with finite scheduling tools and allocation of resources and equipment
• Six Sigma certification

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.

To prevent the spread of COVID-19, and as an integral part of its public health and safety measures, Seagen requires that all newly-hired employees be fully vaccinated against COVID-19 before commencing employment, subject to reasonable accommodation and other requirements of applicable federal, state, and local law.

Apply:

Seagen

Seagen is an Equal Opportunity Employer

Submitted: 07/15/2022