Seagen

Senior Scientist Quality Control Microbiology - Launchpad

Technical Operations & Process Sciences - Bothell, United States

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).

The QC Microbiology Sr. Scientist performs and oversees microbiological sampling, testing, and data analysis for the site’s environmental monitoring (EM) program. This position is responsible for the design and execution of environmental monitoring programs for classified spaces, GMP utilities, and critical aseptic operations. Key responsibilities include authoring of EM risk assessments and procedures, oversight of EM qualification studies, and ongoing data trending and analysis. This position also provides technical expertise on the site’s microbial control strategy, cleaning program, gowning qualification, and related functions. The Launch Pad QC Microbiology laboratory will support drug substance and sterile drug product manufacturing for both clinical and commercial products and will work closely with other Seagen sites to ensure the safety and compliance of our products and manufacturing operations.

This position reports to the Sr. Manager of Quality Control Microbiology – Launch Pad.

Principal Responsibilities:

• Design, author, and implement the environmental monitoring programs for a large-scale biologic drug substance and sterile drug product manufacturing facility, including Grade A – D classified spaces, GMP utilities (e.g., WFI, compressed gasses) and personnel monitoring.
• Lead environmental monitoring performance qualification (EMPQ) studies during site startup and following modification, expansion, or periodic shutdown activities.
• Author, review, and approve risk assessments and procedures defining and justifying routine EM sampling, testing, and reporting requirements.
• Compile, analyze, and report EM data on a routine basis and provide actionable information to detect risks and keep the facility in a continual state of control.
• Train and support QC, QA, and Manufacturing staff on aseptic technique, gowning, personnel monitoring, and related functions.
• Work closely with other QC Microbiology staff to schedule and track EM sampling, testing, and data review
• Lead or support environmental monitoring excursion investigations in both the QC laboratory and Manufacturing operations
• Identify opportunities for continuous improvement in cleaning, gowning, sampling, or other operations that reduce risk, increase GMP compliance, or enable more efficient operations
• Act as subject matter expert on the EM program during audits and inspections

Expecteded Qualifications:

• 12+ years relevant GMP/QC experience
• Bachelor's or Master’s degree in microbiology, biology, or a related discipline
• Extensive knowledge of environmental monitoring program requirements for aseptic and sterile manufacturing operations, GMP utilities, and personnel gowning
• Demonstrated experience authoring and revising risk assessments related to classified spaces, WFI, clean steam, and GMP compressed gasses
• Ability to analyze and identify trends in EM data, establish appropriate action and alert limits, assess risk associated with process or facility changes, and determine appropriate mitigations for common cause and special cause excursions
• Technical expertise in QC Microbiology, including bioburden, endotoxin, TOC, total air particulates, and air / surface viable monitoring
• Experience with common laboratory software systems used for EM data trending such as MODA, LIMS, or JMP
• Experience supporting internal and health authority audits and inspections

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 $114,000 - $147,000 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.

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Seagen

Seagen is an Equal Opportunity Employer

Submitted: 03/03/2023