Seagen

Senior Quality Control Analyst - 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!

Summary:

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

The QC Sr. Analyst is responsible for providing microbiologic expertise, investigative support and contamination control leadership ensuring that the site maintains robust aseptic control over the manufacturing environment. This position will accomplish this by providing the necessary support and quality oversight of processing, environmental monitoring, cleaning and disinfection, access and flow, gowning, facilities and utilities programs. This role is expected to enhance the presence of contamination control on the production floor and help identify potential issues to ensure continued compliance and audit readiness state.

Principal Responsibilities:

• Interpret and report disinfectant efficacy study data and maintain the program.
• Design and lead training courses on microbiological and contamination control topics.
• Work with cross-functional teams to provide contamination control expertise Create, execute, and maintain an aseptic gowning program.
• Maintain the cleaning validation testing program.
• Support for EM excursions, quality systems, risk assessments and impact assessments related to routine production.
• Author and revise test methods, operational procedures, and study reports.
• Review, interpret and approve testing data generated from the QC microbiology laboratory.

Expected Qualifications:

• 8+ years relevant GMP/QC experience. Bachelor's degree or associates degree and 2+ years in Microbiology or relevant field
• Ability to understand and translate regulatory and guidance documents
• Strong understanding and proven experience having performed EM and utility testing
• Experience with QC equipment and laboratory testing such as TOC analyzers and particle counters
Strong analytical and problem solving skills
• Excellent customer service skills, communication, and collaboration skills
• Experience with managing data in relational databases (e.g., LIMS) and query/reporting applications
• Experience in a GMP testing and manufacturing environment

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 $94,000 - $121,000 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.

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: 10/13/2023