Seagen

Senior Quality Control Analyst

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:

This role performs complex testing for transfer, qualification, and validation for test methods/instrumentation with advanced proficiency and general QC laboratory work in a GMP environment with guidance provided as needed. The ideal candidate will have oversight and participation in routine transfer, qualification, and validation of test method and equipment with minimal guidance.

Principal Responsibilities:

• Applying the principles of good manufacturing practices (GMP) on a daily basis
• Authoring and owning complex deviations, CAPAs and Change Controls
• Approving standard operating procedures (SOP’s) and other documents
• Identifying and leading continuous improvement projects
• Performing routine maintenance of QC lab equipment, procedures, and systems
• Performing testing/reviewing for transfer, qualification, and validation for test methods/instrumentation
• Mentoring junior analysts
• Troubleshooting laboratory or system anomalies
• Own and approve training standards and curriculums
• Serving as SME for Test Methods, Validation Protocols, and other documents
• Leading and supporting special projects for potency/analytical problem solving
• Approving, analyzing, and compiling data and preparation of reports
• Method or system development and/or optimization
• Representing QC in cross-functional teams
• Providing oversight for programs, specific to job function (i.e., Microbiological)

Required Qualifications:

• Associate degree in a relevant field with 10 years of experience or a Bachelor's degree with 8 years of experience
• Highly organized with an attention to detail
• Knowledge of biological and/or chemical handling
• Strong data interpretation/analytical skills
• Strong troubleshooting skills
• Strong knowledge of GMP compliance
• Strong technical writing and communication skills
• Experienced in lab equipment (HPLC/UPLC, CE/icIEF, etc.)
• Experienced authoring or revising of complex Standard Operating Procedures
• Good communication and collaboration skills
• Participation in Laboratory Investigations and OOS
• Ability to keep order of multiple projects/tasks
• Authoring Change Controls, Deviations and CAPAs
• Experience with regulatory inspections
• Good customer service skills

Preferred Qualifications:

• Experience with Automation/Liquid Handlers (Tecan/Hamilton)
• 4+ years of experience working in a GMP laboratory
• Experience with Test Method Qualification and/or Validations

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 to $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 (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: 02/17/2023