Senior Specialist Quality Control

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!

Position Summary:

This position acts as liaison between Quality Control (QC) analysts performing testing, facilities personnel maintaining laboratory instrumentation and equipment, IT, and QA, and the supporting software systems that track equipment implementation, maintenance, and usage. This position is dedicated to one QC site but may provide backup to other QC sites.

Principal Responsibilities:

• Work with QC, Facilities, IT, and QA to ensure equipment and associated software is managed in accordance with governing procedures
• Create new and review completed equipment records and tasks in the CMMS (computerized maintenance management system) as the System Owner
• Take lead role for equipment changes
• Write and revise equipment and software related documents (user requirements specifications, qualification/validation protocols, etc.)
• Review executed equipment testing protocols and address exceptions that occur during testing execution by vendor or Facilities
• Address equipment alarms such as for temperature excursions including moving material to alternate storage unit, performing investigations into the cause for the excursion and assessing impact of the temperature excursion
• Arrange purchase and receipt of new equipment
• Perform data integrity and impact assessments for equipment and associated software
• Perform periodic reviews of equipment and associated software as the System Owner
• Perform equipment logbook reviews
• Coordinate with Facilities for scheduling calibration, maintenance, and repairs
• Work with QC Systems colleagues, Facilities, IT, QA, and customers to create and implement process improvements
• Support other equipment System Owners as needed
• A few hours of evening, weekend, and/or on-call work may be occasionally required to address equipment alarms
• May administer training system for a QC site including but not limited to user access, organizing training assignments, providing customer support for questions
• Apply the principles of good manufacturing practices (GMP) on a daily basis
• Create and revise standard operating procedures (SOP’s) and other documents as needed
• Identify and lead continuous improvement projects
• Maintain training to current standards and procedures on all assigned curriculums
• Fully comply with company health and safety procedures and practices
• Author and own deviations and CAPAs
• Train and mentor other personnel
• Represent QC in cross-functional project teams
• Participate as subject matter expert (SME) in regulating agency inspections, internal audits, and partner audits

Expected Qualifications:

• 10+ years relevant experience
• Bachelor’s degree or associates degree and 2+ years in relevant field
• Ability to quickly adjust and re-prioritize current tasks based on strategy or timeline changes from sources within QC Systems, within QC, or outside of QC with little lead time or notice
• Excellent customer service skills
• Excellent communication and collaboration skills
• Experience with Blue Mountain, Maximo, or other equipment maintenance management system
• Experience using or managing analytical lab equipment (pH meters, balances, HPLCs, etc.)

Preferred Qualifications:

• Familiarity with general function of QC equipment (spectrophotometers, HPLCs, particle counters, CEs, plate readers, plate washers, freezers, refrigerators, incubators, pH meters, fume hoods, BSCs, etc.)

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.

The hiring pay range for this position is $103,000 to $133,000 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 (with additional annual grants, and grants upon promotion when applicable), and an annual bonus.

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.

#LI-JW1