Senior Principle Scientist Method Development

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 over 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.

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.

What the Principal Scientist, Method Development does at Worldwide:

A Principal Scientist, Method Development adapts existing procedures for new objectives, transfers procedures, and develops complex procedures with no oversight. They have demonstrated scientific leadership and become recognized as a scientific leader. Principal Research Scientists regularly contribute to literature and building Worldwide intellectual property. They are capable of leading interdisciplinary project teams.

What you will do
Tasks may include but are not limited to:

• Develop complex bioanalytical methods for our clients
• Develop new bioanalytical processes to improve efficiency and quality
• Train staff in new bioanalytical methods, processes, and technologies
• Conduct research studies including drug metabolism studies
• Evaluate the potential to automate work practices and, whenever possible, implement it
• Able to quickly identify liabilities of an assay using a standardized testing procedure
• Operating Procedures, Employee Handbook, and Health and Safety Manual
• Transfer and optimize client-owned assays
• Adapt existing assays for new objectives
• Validate assays, as needed
• Work closely with others to ensure that methods are effectively validated and used
• Evaluate and implement new technologies
• Perform routine chemical assays with consistent accuracy and precision
• Produce technical documents, publications, posters, reports, or communications
• Prepare standard operating procedures
• Represent Worldwide with an external poster or podium presentations
• Understand and apply regulatory guidelines when applicable
• Clearly document procedural processes
• Maintain instrumentation to the highest standards of performance
• Participate in investigations as the technical expert and determine assignable causes for unexpected events
• Review data to recognize and report inconsistencies
• Work independently, when required, to conduct and plan laboratory work
• Interface with clients and provide regular oral and written communication of method progress
• Follow Worldwide’s safety guidelines and perform tasks in a safe manner
• If assigned, function as a lab monitor or safety committee member
• Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.

What you will bring to the role

• Lead or represent project teams focused on a narrow area of expertise
• Established knowledge of separation science
• Established knowledge of mass spectrometry
• Ability to read, execute, and understand complicated and detailed instruction and technical literature to plan, perform, and direct laboratory activities
• Excellent attention to detail
• Advanced knowledge of industry regulations in bioanalytical method validation; FDA and EMA
• Expanding knowledge of industry regulations in drug development (i.e., MIST, BE/BA)
• Established knowledge of quantitative analysis and experience with its application to biological samples
• Must be able to work with constant interruptions
• Familiarity with corporate policies, goals, and objectives; normally acquired after three months of on-the-job exposure to Worldwide operations
• Familiarity with various divisions of Worldwide; normally acquired after 1-year on-the-job training

Your experience

• Ph.D., or postgraduate degree, with a scientific focus, preferred
• Bachelor’s degree, in a science discipline, and 12 or more years of relevant work experience required

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