Seagen
Lab Data Operations Manager
Development - Remote, 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 Lab Operations Manager oversees the day-to-day management of staff and vendors assigned to them. This individual has thorough knowledge of external central and third-party testing lab(s) processes and ensures contracted lab vendors, Seagen Clinical Study Teams, and staff reporting to them have the proper support. The Lab Operations Manager 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
Qualifications:
- Minimum 5 years of relevant experience including working with Central Labs, Biomarker, and Bioanalytical testing labs
- Strong leadership and mentoring skills
- Strong understanding of the industry as it relates to the central and third-party testing lab players and processes
- General understanding of GCP and GLP requirements
- Prior experience writing, and / or reviewing, lab specification documents and work instructions
- Interpersonal skills; encourages collaboration, is a team player and is cooperative, builds constructive and effective relationships, is approachable, communicates effectively
- Flexible, easily adapts to change, and is energized by challenges and problem-solving
Education:
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.
The hiring pay range for this position is $119,000 to $154,000 per year based on skills, education and experience relevant to the role. Other components of total compensation include a competitive equity grant at the time of hire (with additional annual grants, and grants upon promotion when applicable), and an annual bonus.
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: 01/13/2023
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