Seagen

Director, Head of Quality Control - Project Launch Pad

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!

Position Summary:

The Launch Pad Site Quality Control Head (QC Head) is responsible for developing, implementing, and leading a diverse Quality Control organization from the ground up and throughout the various phases of design, construction, commissioning and qualification, and operationalization of our new greenfield manufacturing site (DS, DP, and Packaging) in Seattle.

The QC Head oversees all in-process, release, facility monitoring, and microbiologic testing performed by the Launch Pad QC Laboratory. The QC Head sets the strategic direction for Launch Pad QC function, collaborate with Managers/Supervisors to ensure QC Analysts are trained, and set group goals that align with overall Global Quality objectives. The Launch Pad QC Head works cross collaboratively with key stakeholders to understand the testing needs for commercial and clinical products. They ensure key training and testing metrics are within expectations. This position is also responsible for the inspection-ready state of all QC Laboratories and works closely with all appropriate subject matter experts to represent their area of expertise in regulatory inspections/partner audits. Launch Pad QC Head is a permanent and active member of the Site Quality Leadership Team.

Principal Responsibilities:

• Provide leadership, vision, and set strategic direction to the Launch Pad Quality Control Testing Group at the site.
• Build strong relationships and trust with key stakeholders to understand the site strategy and anticipate future needs from QC to deliver on the strategy.
• Collaborate with Managers and Supervisors to oversee day-to-day tasks, training, goal setting and career development for direct reports.
• Make Quality decisions around complex issues associated with sub-function/area of expertise that may impact key program and/or inter-department processes.
• Ensure Quality Control testing at Seagen is in compliance with corporate policies and procedures, and all federal and applicable international regulations.
• Ensure in-process, release, facility and microbiologic samples are scheduled appropriately and executed within expected timeframes.
• Make sure the Quality Control Laboratories is always in an inspection-ready state and key subject matter experts are identified to represent key lab activities.
• Oversee organization of the execution of test method transfers, qualifications, and validations.
• Collaborate within individual QC teams, Global Quality and individual functions (i.e. development).
• Develop, monitor and report on QC activities, establish KPI’s and provide updates to senior leadership.
• Accountable for the QC part of the site Management Review, and for the APQR sections related to the commercial product manufactured and tested at the site
• Define expense budget planning and project resourcing schedules.
• Lead operational excellence activities such as LEAN initiatives across the QC labs to drive efficiencies and optimization of processes and performance.
• Build a strong team including hiring a diverse QC workforce, workload management, coaching/mentoring, development, and performance management.
• Develop meaningful sets of Key Performance Indicators (KPI’s) to monitor progress with the various phases of development of the QC lab and site (e.g. from construction to registration)

Required Qualifications:

• BS/MS degree or equivalent in scientific, quality-related field, biology, chemistry, or pharmaceutical studies, or an equivalent combination of education, training and experience.
• At least 18+ years of relevant experience leading analytical activities in a Pharmaceutical or Biotech industry in a GMP environment.
• Minimum of 7+ years/ of people management and mentoring experience.
• Ability to establish and manage multiple competing priorities and proceed with objectives with minimal supervision.
• Demonstrated leadership experience building and leading high performing Quality Control and analytical teams.
• Highly collaborative with outstanding relationship building skills.
• Strong organizational skills, attention to detail and be able to effectively handle multiple projects or activities simultaneously.
• Adept at leading people, mentoring, and developing other leaders within the group.
• Excellent communication skills.

Preferred Qualifications

• Experience leading or participating in regulatory inspections
• Green field experience and building up quality teams from the ground up
• Hands on experience leading and implementing continuous improvement, operational excellence and six-sigma programs in a QC laboratory environment (e.g. LEAN Lab, Black/Green belt certification) would be an asset

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: 05/27/2022