Seagen

Senior Manager Biological QC Lead

Technical Operations & Process Sciences - Bothell, Washington

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!

Summary

Senior Manager, Quality Control Lead (QCL), has advanced technical skills in analytical development or QC area, is an experienced people manager that oversees a group of QC Leads within the Commercial QC group.

Responsibilities:

• Manage a group of skilled individual contributors, QC Leads, the point of contact (PoC) of QC for assigned market products
• Responsible for the employee performance process and career development for the team
• Oversee implementation of QC strategies for commercial biological products, setting goals and managing toward these deliverables
• Building the team to achieve commercial product goals through collaboration with internal stakeholders and external partners
• Oversee or manage commercial products testing strategies, product analytical lifecycle management, second source tech transfer & validation, product in-country testing, and support regulatory submissions and interactions
• Represent QC in inter-department project/initiative or cross-functional teams in support of program and company goals. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions
• Overseeing and managing continuous improvement projects to optimize QC processes
• Can serve as QC Lead role in market product team
• Manage the capacity for the assigned QC Lead team and escalate capacity bottlenecks to QC Leadership Team (QCLT), if necessary
• Ensure alignment amongst QC Leads on the implementation and application of QC strategy for post-approval changes
• Keep the QCLT updated on the progress and changes of the activities of the group

Qualifications:

• Bachelor’s degree in life science (post-graduate degree in a related field is a plus) in biology, biochemistry, or any related technical discipline
• A minimum of 10 years relevant experience in pharmaceutical/biological drug product development, analytical chemistry and/or quality control in a regulated biotechnology, pharmaceutical company with progressive levels of responsibility are required (recommended 14+ years overall relevant experience)
• A minimum of 3 years’ experience of people management or leadership experience
• Demonstration of leadership within a laboratory environment
• Possess strong data interpretation, method troubleshooting, skills and sounds scientific judgement
• Strong time management skills with attention to detail and desire to achieve team and individual goals
• Excellent communication skills
• Familiarity with regulatory guidance and requirements (ICH, CFR, general guidance), regional pharmacopeias, regulatory submission such as BLA, MAA, etc.
• Good communication skills to lead a team and influence other leaders or cross-functional team members
• People management skills to coach employees in daily performance, setting functional team or group goals and employee career development
• Excellent analytical mindset and strong technical knowledge on analytical methods, or biological methods and compendial testing, etc.
• Experience with QC related Audits or Health Authority Inspections

• Hands-on QC Lead experience with biologics (including ADC) or small molecules, aseptic products (both liquid and lyophilized forms)
• Strong project management skills and experience managing multiple projects at the same time is essential
• Experience in preparing and coaching team members for impactful presentations and interactions with key stakeholders, e.g., internal senior management, health authority consultations and interactions

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: 04/15/2022