Lab Operations Manager Jobs

Position Summary

The Associate Lab Operations Manager assists with the day-to-day management of studies and vendors assigned to them. This individual has knowledge of external central and third-party testing lab(s) processes and ensures lab vendors contracted to Seagen, and Seagen Clinical Study Teams, have the proper support to 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. This role possesses knowledge of GxP, FDA regulations, vendor-sponsor best practices, strong technical skills, and is capable of supporting infrastructure assessment and improvement.
Principal Responsibilities

• Serves as escalation point for vendors assigned from study teams across Seagen’s portfolio. Works closely and collaboratively with our Vendor Strategy Management team and Senior Leaders to resolve vendor concerns and milestones.
• 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.
• Assists with developing presentations and presenting metrics at team meetings.
• Preparation and review of clinical study documents such as lab specification documents, sample management plans, and laboratory manuals.
• Support the oversight of external, and internal, Biomarker and Bioanalytical labs assigned to them ensuring proper vendor execution and oversight across the Seagen portfolio.
• Attends Clinical Study Team meetings as needed to provide lab vendor support during start-up, amendments, and escalations.
• Identifies, develops, and supports implementation of risk mitigation strategies associated with lab vendors as needed across programs.
• 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.

Qualifications

• Strong understanding of the industry as it relates to the central and third-party testing lab players and processes
• Prior experience writing, and / or reviewing, lab specification documents and work instructions
• General understanding of GCP and GLP requirements
• Minimum 4 years of relevant work experience including working with Central Labs, Biomarker, and Bioanalytical testing labs

• Flexible, easily adapts to change, and is energized by challenges and problem-solving
• Interpersonal skills; encourages collaboration, is a team player and is cooperative, builds constructive and effective relationships, is approachable, communicates effectively

Education

• BS in a Life Science; years of experience may substitute for education