Description
Position at SeagenSeagen 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 routine and non-routine testing with expert proficiency and general QC laboratory work for the in-process support, release and/or stability of Seagen’s clinical development and/or commercial products in a GMP testing environment. Must be able to work weekends, off-shifts, and overtime as required. Holiday work may be required. Applicant must be willing and able to work reliably on a flexible schedule, Monday – Friday and some weekends, to meet the demands of the project.Principal Responsibilities:
Applying the principles of good manufacturing practices (GMP) on a daily basis
Performing sample testing for stability or release testing
Analyzing and compiling data and preparation of reports
Reviewing assays/data for compliance to specifications and reports abnormalities
Creating and revising standard operating procedures (SOPs) and other documents as needed
Identifying and leading continuous improvement projects
Supporting special projects for analytical problem solving
Participating in the qualification and validation of test methods
Troubleshooting laboratory or system anomalies
Authoring and owning deviations, CAPAs, and Change Controls
Method or system development and/or optimization
Training other personnel
Serving as SME for Test Methods or other areas of expertise
Providing oversight for programs, specific to job function (., Analytical Chemistry)
Representing QC in cross-functional teams
Required Qualifications:
Associate’s degree in a relevant field with 2 years of experience or a Bachelor's degree in a relevant field (in addition to 8+ years of relevant experience) or a Master’s degree in a relevant field (in addition to 5+ years of relevant experience)
Broad experience with Microsoft Office products
Be highly organized with an attention to detail
Strong data interpretation/analytical skills
Strong troubleshooting skills
Strong knowledge of GMP compliance
Strong technical writing and communication skills
Experienced in various analytical lab equipment (balances, CE/iCIEF, HPLC/UPLC, osmometers, pH meters, pipettes, plate readers, SoloVPE,
Experience authoring or revising SOPs
Familiarity with Change Controls
Participation in Laboratory Investigations
Ability to keep order of multiple projects/tasks
Preferred Qualifications:
4+ years of experience working in a GMP laboratory
Participation in Laboratory or Out of Specification Investigations
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.
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