Description
Position at Seagen
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 :
This position supports daily sample management operations to ensure samples are available for Quality Control to test (received from or sent to the correct internal and external locations) and ensurecomplete chain of custody ismaintainedin accordance with standard operating procedures (SOPs) in a cGMP compliant QC laboratory.
This position is dedicated to one QC site but mayprovide backup to other QC sites.
Principal Responsibilities :
Perform routine sample management activities, including sterile sample aliquotting and proper storage and disposal of samples
Perform sample receipt and prepare outgoing shipments
Coordinate with external contract testing laboratories for sample submission and testing
Complete and review chain of custody documentation, temperature data, and LIMS entries
Archive chain of custody documents and other QC documentation as needed
Perform routine maintenance on sample management laboratory equipment, such as cleaningBSCs, refrigerators, and freezers
May create advanced testing templates in LIMS
May be subject matter expert for sample management in audits and regulatory agencyinspections
Assist the LIMS team in system troubleshooting and process improvements
Perform periodic inventory of product samples and product reference materials
Maintain close communication and interaction with QC lab leads and manufacturing staff to ensure on-time distribution of samples
May set up elements in systems integrated with LIMS to auto-report stability data (.,Discoverant)
Evening, weekend, and / or on-call work may be required
May assist in equipment management including but not limited to reviewing equipment logbooks, reviewing tasks in maintenance management system, and coordinating with Facilities forscheduling maintenance and repairs
Apply the principles of good manufacturing practices (GMP) on a daily basis
Create and revise standard operating procedures (SOP’s), work instructions, and otherdocuments as needed
Identify, participate in, and / or lead continuous improvement projects
Author and own deviations, CAPAs, and change controls as needed
Train other personnel
Maintain training to current standards and procedures on all assigned curriculums
Fully comply with company health and safety procedures and practices.
Expected Qualifications :
2+ years relevant experience
Bachelor’s degree or associates degree and 2+ years in relevant field
Be highly organized with an attention to detail
Ability to keep order of multiple projects / tasks
Preferred Qualifications :
Experience authoring and / or revising Standard Operating Procedures
GMP experience
Experience with a LIMS or other sample / inventory management system
The hiring pay range for this position is $70,000 - $90,000 per year based on skills, education and experience relevant to the role.
Other components of total compensation include a competitive equity grant at the time of hire and an annual bonus.