Seagen

QC Analyst III/Senior QC Analyst

Description

Summary

The Quality Control unit at Seagen is seeking an experienced professional to join the stability team. This position will assist in managing the QC stability program for all GMP intermediates, drug substances, and drug products for clinical and commercial programs. This individual should have experience in stability-related areas such as: coordinating, performing, or reviewing stability testing; entering/compiling stability data; evaluating results/trends; maintaining stability protocols and reports.

Responsibilities:

• Generate stability documentation (protocols, reports, data tables) for internal requests and to support stability sections of regulatory submissions and annual Product Quality Reports
• Prepare product expiry dating documents and assist in establishment of product shelf-life
• Support QC Lead in designing product stability protocols aligned with program strategy and current regulatory requirements
• Oversee stability study initiation, review stability template in LIMS, track time points for testing, and ensure stability studies are executed according to protocol
• Stability data review, management, and trending for assigned programs
• Evaluate stability results to support expiry extensions and conditions for real-world use
• Escalate unexpected data/trends and risks appropriately, and drives/supports resolution
• Provide support in regulatory inspection, audits for stability business processes, including implementation of corrective actions

Required Qualifications:

• BS in life science field with 5+ years (Analyst III) or 8+ years (Sr. Analyst) working experience in pharmaceutical or biotech field.
• Familiarity with pharmaceutical and biological product stability testing.
• Some laboratory experience in QC or development is preferred but not required.
• Familiarity with cGMP and regulatory requirements (ICH, USP, guidance documents)
• Able to manage multiple high priority projects and multiple tasks while maintaining direction and adherence to timelines
• Good communication in presentation and written form to staff at all organizational levels
• Experience working on a cross-functional team

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: 03/26/2021