Seagen
Quality Control Tech Transfer Analyst III
Technical Operations & Process Sciences - Remote, Bothell, United States
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
Performs advance testing for transfer, qualification, and validation for test methods/instrumentation with advanced proficiency and general QC laboratory work in a GMP environment with minimal guidance provided.
Principal Responsibilities:
- Applying the principles of good manufacturing practices (GMP) on a daily basis
- Authoring and owning deviations, CAPAs and Change Controls
- Creating and revising standard operating procedures (SOP’s) and other documents as needed for change or improvement
- Identifying and participating in 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
- Training other personnel
- Troubleshoot laboratory or system anomalies
- Maintain training to current standards and procedures on all assigned curriculums
Required Qualifications:
- Associates degree in a relevant field with 7 years of experience or a Bachelor's degree with 5 years
- 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 (pH meters, balances, pipettes, HPLC's/plate readers, etc.)
- Experienced authoring or revising Standard Operating Procedures
- Good communication and collaboration skills
- Participation in Laboratory Investigations
- Authoring Change Controls, Deviations and CAPAs
Preferred Qualifications:
- 3+ years of experience working in a GMP laboratory
- Ability to keep order of multiple projects/tasks
- Experience with regulatory 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.
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.
To prevent the spread of COVID-19, and as an integral part of its public health and safety measures, Seagen requires that all newly-hired employees be fully vaccinated against COVID-19 before commencing employment, subject to reasonable accommodation and other requirements of applicable federal, state, and local law.
Apply:
Seagen
Seagen is an Equal Opportunity Employer
Submitted: 07/08/2022
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