Panel Team or Test Lab Supervisor - Research & Development

Job description

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries.

JOB DESCRIPTION:

Panel Team or Test Lab Supervisor - Research & Development

Overview

Supervise a team of 10+ individuals providing daily guidance to complete panel preparation and/or design verification testing/witness.  Provides scientific expertise and assay technical knowledge throughout the development and implementation of clinical evaluations, risk management, clinical studies and/or verification studies. Writes/manages clinical evaluation (plans and reports) or clinical trial protocols, verification protocol amendments, interacts with various study support groups cross-functional teams in order to assist in clinical strategy, the development of plans, reports and project deliverables. Interacts with regulatory agencies as needed, and will use their scientific and medical knowledge in order to provide directives to staff as well as study sites as directed by your manager.

Responsibilities:

Lead Panel team - scheduling and planning weekly panel schedule, communicate with CFT and technical group by sending out weekly panel prep update email, assign preps based on team member skill for efficiency, review panel request forms for accuracy, update Panel Team folder on J drive with panel request forms and team. Work with technical leads on panel solutions if there are discrepancies or issues with the prep. Plan any panel troubleshooting and answer related questions. Write ELNs for sample receipt, perform ELN witnessing for team as needed. Need to understand and evaluate panel data and understand statistical analyses to determine if panels can proceed. 

Supervise Core Test Lab – work with department scheduler to support proper level loading of testing across scientists.  Collaborate with peer supervisors to ensure consistency across the lab and provide development opportunities to direct reports. Work with investigation team to resolve test issues. Drive completion of testing packages and witness activities to completion.  Field questions regarding protocols, testing schemes and assays from direct reports. 

General supervisory activities -  schedule and plan team meetings and team building activities.  For contractors, review and approve Fieldglass timesheets, schedule 1:1 meetings and provide guidance. For FTE’s, hold bi-monthly 1:1 meetings, write performance assessments in Workday, provide guidance on goals and professional development  

Experience with PEAR, EDMS, RSLMS and APLM preferred.  

Responsible for requesting quotes from vendors and for following up, work with specimen bank and fill out required forms for serum/urine/CSF orders, write receipt ELNs, work with team members for any help that is needed to expedite orders in SAP 

Spot Ordering and OneLab access – order reagents/cals/controls for panel.

Attend any scheduled meetings and respond to emails in a timely fashion.  

Project management and organization- for example, there are many tasks related to panel prep to keep track i.e. inventory of analytes, matrix, timelines, patient samples, shipping etc.  Interface with other disciplines/cross functional teams, customers, internal clients, project staff and internal and external experts as required.  Identifies,authenticates,and responds to crises in a professional manner,assembles appropriate resources to deal with and resolve the situation effectively,keeps emotions in control during periods of high stress,leads by example. Prepare and present written and oral reports and other presentations to senior management and internal audiences.

Attend EHS safety walk throughs and support internal/external audit readiness. Maintain compliance with regulatory agencies, quality system and project goals. Assure that Design Control and compliance requirements are met.

Perform project tasks as assigned- this requires use of technical knowledge.  Projects may require writing and reviwing technical documents, justifications, memo’s and ELNs, planning everything related to getting the project executed as needed, answer questions and provide requested information to CFTs, review submission records and sign off for migration studies, shipping materials to clinical sites etc.

Minimum Qualifications:

• Bachelor's degree required, advanced degree preferred. Degree in the sciences, medicine, or similar discipline highly preferred. 
• Minimum of 8+years of related work experience with a complete understanding of specified functional area, or an equivalent combination of education and work 

Preferred Qualifications:

Leadership, accountable, support quality system, technical Writing, problem solving, take initiative, project management, good organizational skills, clear communicator, good computer skills, technical knowledge, data analysis, supervision, mentorship, collaborative, flexible.

We are open to considering candidates who have a lower level of experience.

JOB FAMILY:

DIVISION:

LOCATION:

ADDITIONAL LOCATIONS:

WORK SHIFT:

TRAVEL:

MEDICAL SURVEILLANCE:

SIGNIFICANT WORK ACTIVITIES: