Clinical Process Development Associate III

The Genomics Platform is dedicated to solving the worlds most challenging biomedical problems through the continuous development and investment in cutting edge technology and large-scale genome sequencing research projects that are both challenging and complex.

In support of continually changing initiatives the Clinical Process Development Associate III is committed to developing innovative research processes and pursuing the highest quality research to realize the full promise of genomic medicine.

Demonstrates exemplary proficiency in all key responsibilities for all preceding roles (PDT-PDA 2)

PRINCIPAL DUTIES AND RESPONSIBILITIES

Subject matter expert and responsible for all protocols (standard and non-standard) in primary functional area

Global understanding of connectivity between lab workflows and processes

Advanced understanding and responsible for all standard protocols in additional workflows and processes

Monitors daily workflow ensuring that metrics are tracked and reported in various databases on a regular basis

Expertly identifies in-process problems and investigates to determine root cause. Presents findings and informs necessary stakeholders as needed. Initiates mitigation steps for corrective and preventative measures

Strong understanding of how potential lab deviations impact quality metrics and deliverables

Responsible for identifying continuous improvement opportunities and escalating to supervisor and Change Management Team

Strong understanding and knowledge of techniques instrumentation platforms and underlying scientific principles

Proficient in platform standard software and analytical packages

Awareness of larger lab structure and ability to identify internal stakeholders for collaboration and support efforts

Can serve as a resource for onboarding and cross training new PDAs

Provides mentorship to team members inside or outside of primary functional area

Assists team in updating A3 Problem Solving and Continuous Improvement projects

Actively and enthusiastically acquires additional knowledge trainings and skills

QUALIFICATIONS

4 years of relevant full time clinical laboratory experience in this specialty preferred and a B.S./B.A. degree OR M.S. degree with 2 years experience (CLIA number will need to be provided)

Duties are approximately split 50/50 between production lab workflows and development work/continuous improvement efforts

Liaison and contact between primary functional area and Research and Development or Change Management/Continuous Improvement Teams to conduct experiments

Heavily involved in implementation of new products or major workflow changes in primary functional area

Point of contact for lab groups outside of their primary function for all biological and chemistry related questions