PK Lead Scientist
Location: Austin, TX, USA
Requisition Number: 4792
Position Title: Assay Lead Scientist, Supervisor
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 2,500 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 you will do
SUMMARY: Assay Lead Scientist, Supervisor will independently perform ligand binding assays for supporting development, validation, and analysis projects.
• Independently perform Large Molecule PK assay including ELISA, MSD, and others.
• Be familiar with bioanalytical guidance (FDA, EMA and ICH M10)
• Receive GLP or GCP trainings
• Develop, optimize, and troubleshoot plate-based ligand binding assays using various platforms (e.g., ELISA, MSD…) to support regulated PK programs.
• Lead PK team to assay design and troubleshooting on large molecule modalities (e.g., mAb, ADC, fusion protein, bispecific…)
• Prepare or provide scientific review of bioanalytical data and methods, protocols, and reports
• Work closely with functional leads to ensure that methods are effectively implemented and coordinate/complete method set-ups to ensure timelines are met
• Understand and apply GLP guidelines in all aspects of work and ensure staff compliance with SOP’s, safety, and other guidelines.
• Manage, monitor, and support employees regarding performance, training, and goals
• Interface with clients, when necessary and participate in sponsor audits.
• Strong scientific and compliance support to large molecule PK programs
• Ability to independently perform LM PK assignments
• Must be able to work well with a variety of laboratory personnel and leadership (preferred).
• Excellent attention to detail, strong written and oral communication skills
• Bachelor’s degree with > 5 years or Master’s degree with >2 years of relevant work experience
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!
Employment Type: Regular
Community / Marketing Title: PK Lead Scientist
We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.
Location_formattedLocationLong: Austin, Texas US
CountryEEOText_Description: Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law. Worldwide is committed to working with and providing reasonable accommodations to applicants with disabilities. We are proud to be an equal opportunity workplace where people thrive by being themselves and are inspired to do their best work every day.