Who we are

We’re a global, midsize CRO that pushes boundaries, innovates, and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.

We are Worldwide Clinical Trials, and we are a global team of almost 3,500 experts, bright thinkers, dreamers, and doers, and, together, we are changing the way the world experiences CROs - in the best possible way.

Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.

What the Sr. Automation Scientist does at Worldwide

Worldwide Clinical Trials is seeking a seasoned Sr. Automation Scientist to join our team in the early phase clinical trials department. This is a senior-level position that expects the candidate to lead the team for transferring the manual Large Molecule assays (e.g., PK, ADA, and biomarker) into Hamilton bioanalytical automation system.

The successful candidate will be responsible to prepare and optimize assay scripts, track automation performance, support system maintenance, and provide training to corresponding teams.

What you will do

• Lead the transfer of manual LBA assays (validation and sample analysis) to automated instrumentation in 96/384-well formats.
• Prepare, test, and optimize assay scripts using Hamilton Software Platform (Venus) for validation and sample analysis runs of PK, ADA, and biomarker studies.
• Oversee the automation testing for meeting the expectations of assay quality, regulatory compliance, and operational productivity.
• Develop and implement performance metrics and KPIs to monitor system performance and make adjustments as necessary to ensure accuracy and precision.
• Perform maintenance on the integrated automation systems including liquid handling unit, microwell incubation unit, microwell plate washer, MSD, and spectramax
• Contribute to the development and implementation of new assays and laboratory processes using the latest automation technologies.
• Ensure compliance with laboratory safety and regulatory guidelines, and support quality and regulatory audits.
• Train laboratory personnel on the use of automation systems, scripts, and data analysis tools
• Develop and maintain standard operating procedures (SOPs) and best practices for automation workflows
  

Your experience

• Demonstrated ability in creating, optimizing, and troubleshooting bioanalytical assay scripts using Hamilton Software Venus.
• Currently reside within/near or willing to relocate to the Austin, Texas area
• General experience in using ligand binding assays for PK, ADA, biomarker, or potency studies.
• Master's degree in a relevant field (Biochemistry, Biology, etc.) or equivalent experience.
• 7+ years of experience in automation script generation for bioanalytical assays, including at least 2+ years of experience with the Hamilton software platform.
• Expertise in system optimization, performance monitoring, statistical analysis, and troubleshooting of liquid handling automation systems.
• Strong project management and leadership skills, including the ability to prioritize and manage multiple projects and stakeholders.
• Excellent written and oral communication skills, with the ability to explain complex technical concepts to non-experts.
• Knowledge of laboratory safety and regulatory guidelines, including GLP, GCP, and FDA regulations.
• Ability to work independently and within a team, and to lead technical discussions and meetings

Why Worldwide

At Worldwide, we balance fun with the serious business of changing lives. We have a values-driven culture that is built from the ground up. We empower our team members to treat every clinical trial like a patient’s life depends on it - because it does. Our leaders are in the trenches with you - committed to advancing science and moving mountains for our customers.

Interested in hearing more about Worldwide or our roles? Check out our careers page at www.worldwide.com/careers!