Seagen

QC Scientist

Description

Summary

Responsible for managing QC lab activities, mentoring/training QC lab personnel on analytical methods as well as performing release and stability testing for commercial and clinical products. Responsible for leading QC lab investigations and troubleshooting associated with analytical testing. Requires experience in several quality areas such as analytical testing, data review, familiarity with quality systems (change request, deviations, CAPA, OOS, document management), and interpreting, following, and keeping up to date on regulations and guidance documents. Experience with method transfer, method qualification/validation and method bridging. This position requires strong analytical skills especially in-depth understanding of compendial and analytical testing using HPLC (such as SEC, HIC, FDRI, RP-HPLC, Peptide mapping, etc.), CE and iCE systems. Must have strong technical expertise and knowledge of mAb and ADC manufacturing as well as analytical testing in order to train personnel and lead complex lab investigations, method qualification/validation and method bridging. This position will report to an Associate Director level manager.

Requirements:

• Applying the principles of good manufacturing practices (GMP) on a daily basis
• Performing sample testing
• Analyzing and compiling data and preparation of reports
• Reviewing data for compliance to specifications and reports abnormalities
• Creating and revising standard operating procedures (SOPs) as needed
• Identifying and leading continuous improvement projects
• Contributes to optimization of Quality Processes (ex. Laboratory Investigation Procedures)
• Leading special projects on analytical and instrument problem solving
• Participating in and overseeing 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 and mentoring QC Staff
• Serving as SME for Test Methods or other areas of expertise
• Representing QC as SME for regulatory inspections and internal audits
• Providing oversight for programs specific to job function (ie. analytical test methods)
• Representing QC in cross-functional teams

Qualifications:

• 10+ years relevant experience working in biotech or pharmaceutical industry
• BS/BA, MS or PhD in a relevant field
• Strong technical skills and in-depth understanding of compendial methods, analytical testing using HPLC (such as SEC, HIC, FDRI, RP-HPLC, Peptide mapping, etc.), CE and iCE systems
• Highly organized with strong attention to detail
• 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, etc.)
• Experience authoring or revising Standard Operating Procedures
• Authoring Change Controls, Deviations and CAPAs
• Leading Laboratory Investigations
• Experience with Test Method Qualifications/Validations
• Ability to quickly adjust and re-prioritize current tasks based on strategy or timeline changes
• Excellent customer service skills
• Excellent communication and collaboration skills

Preferred Qualifications:

• 6+ years of experience working in a GMP laboratory
• Participation in Laboratory or Out of Specification Investigations
• Participation in GMP Laboratory Investigations

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.

Apply:

Seagen

Seagen is an Equal Opportunity Employer

Submitted: 12/18/2020