Seagen

Lab Operations Manager

Development - Bothell, United States

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

The Manager, Lab Operations Management oversees the day-to-day management of staff and vendors assigned to them. This individual ensures the study level execution of the Lab Vendor Operations Department within the Lab Vendor Operations and Data Management Division. The Lab Vendor Operations Manager has thorough knowledge of external central and third-party testing lab(s) processes and ensures lab vendors contracted to Seagen, Seagen Clinical Study Teams, and staff reporting to them have the proper support. The Manager, Lab Operations Management will ensure proper vendor setup, governance, and timeline development for key trial deliverables involving these vendors. This position requires both hands on study and vendor management as well as staff oversight and ensuring their staff are meeting expectations. This role possesses knowledge of GxP, FDA regulations, vendor-sponsor best practices, strong technical skills, and are capable of leading infrastructure assessment and improvement.

Principal Responsibilities:

• Oversight of external, and internal, Biomarker and Bioanalytical labs assigned to them ensuring proper vendor execution and oversight across the Seagen portfolio.
• Mentors and trains staff to ensure consistency and high standards of excellence across the organization.
• Works collaboratively with internal key stakeholders (e.g. Clinical Project Management, Clinical Operations, Biomarker and Bioanalytical Scientific Study Leads, Data Management) to ensure proper alignment and study level execution of scientific and operational strategies of the lab vendors assigned.
• Works closely with the Biomarker / Bioanalytical Data Management team to support their management of day-to-day vendor oversight after study setup and/or amendments to study protocols.
• Serves as escalation point for vendors assigned from study teams across Seagen’s portfolio. Works closely and collaboratively with our Vendor Services Management team and Senior Leaders to resolve vendor concerns and milestones.
• Attends Clinical Study Team meetings as needed to provide lab vendor support during start-up, amendments, and escalations.
• Preparation and review of clinical study documents such as lab specification documents, sample management plans, and laboratory manuals as well as lab vendor contracts, and change orders.
• Develops presentations and presents metrics at team meetings.
• Leads operational process improvements.
• Identifies, develops, and implements risk mitigation strategies associated with lab vendors as needed across programs

Required Qualifications:

• Minimum 3 years’ experience working with Central Labs as well as Biomarker and Bioanalytical testing labs
• BS in a Life Science
• Strong leadership and mentoring skills

Preferred Qualifications:

• 5 years’ experience working with Central Labs as well as Biomarker and Bioanalytical testing labs
• MSc in a Life Science
• PMP

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: 09/16/2022