Seagen

Quality Control Analyst III - Launchpad

Technical Operations & Process Sciences - Everett, Washington

Description

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:

Seagen’s new cGMP manufacturing facility “project Launch Pad” is being built in Everett, Washington, just North of Seattle. Launch Pad will be a greenfield build encompassing end-to-end manufacturing capabilities for biologics and antibody-drug conjugates (ADCs).

Performs lab support activities and participates in routine and non-routine testing of environmental samples in cleanroom areas. Completes laboratory work for the support and release of Seagen’s products in a GMP testing environment. Must be able to work weekends, off-shifts, and overtime as required. Applicant must be willing and able to work reliably on a flexible schedule to meet the demands of the project. This position will transition to a shift schedule once qualification activities are complete.

Principal Responsibilities:

• Applying the principles of good manufacturing practices (GMP) on a daily basis
• Perform environmental monitoring sampling and testing within the GMP manufacturing facility
• Test WFI for TOC, conductivity, endotoxin, and bioburden
• Perform and maintain aseptic gowning qualification
• Count, record, and Gram stain microbial colonies
• Perform product release testing
• Review data and investigate excursions
• Identify and lead continuous improvement projects
• Maintain training and train others on test methods
• Participates in the qualification and validation of test methods
• Troubleshooting laboratory or system anomalies
• Authoring and owning deviations, CAPAs and Change Controls
• Serve as an SME for test methods

Expected Qualifications:

• 5+ years of experience in a GMP laboratory
• Associate’s degree with 2+ years in a relevant field or a Bachelor's degree in a relevant field (in addition to 5+ years of relevant experience)
• Knowledge of biological and chemical handling
• Broad experience with Microsoft Office products
• Highly organized with an attention to detail
• Strong data interpretation/analytical skills
• Strong troubleshooting skills
Strong knowledge of GMP compliance
• Experienced in lab equipment and software (TOC meters, plate readers, pipettes, etc.)
• Strong technical writing and communication skills, and participation in laboratory investigations

Preferred Qualifications:

• 5+ years of experience working in a QC GMP laboratory performing microbial methods
• Use laboratory management systems for data capture and trending
• Sterility testing and EM in an isolator

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 $83,000 to $108,000 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.

Apply:

Seagen

Seagen is an Equal Opportunity Employer

Submitted: 09/08/2023