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Join a pioneering team in analytical development, supporting method development and validation for therapeutic biologics. This role offers a unique opportunity to contribute to the optimization and robustness of analytical methods crucial for commercial QC labs. You will engage in diverse laboratory activities, ensuring compliance with Good Laboratory Practices while collaborating with cross-functional partners. If you're passionate about scientific innovation and eager to make an impact in the field of therapeutic biologics, this position is perfect for you. Embrace the chance to work in a dynamic environment where your expertise will drive product and process understanding.
Product Development Science and Technology (PDS&T), Analytical Development - Lake County (AD-LC) is a global analytical sciences organization responsible for all CMC analytical activities related to the development of therapeutic biologic products.
Our scope includes a diverse pipeline of innovative therapeutic biologics medicines, including monoclonal antibodies, antibody drug conjugates (Client), and other modalities, and spans support from clinical proof of concept through the transition of analytical methods and testing to commercial labs to support product launch.
The Analytical Development – Lake County group within PDS&T is responsible for support of programs that are preparing for commercial development.
The team leads commercial method development, optimization, robustness, and validation.
In collaboration with cross-functional partners, the team supports commercial formulation and process development studies.
The team also leads tech transfer of final methods to commercial testing labs in Operations QC across the network.
Key deliverables include product control strategies informed by analytical data and method understanding; robust analytical methods suitable for commercial QC labs; comprehensive data packages that drive product and process understanding; clinical supplies release testing and stability studies to establish clinical product dating; substantial clinical trial application and marketing authorization submission content.
The Analytical Development – Lake County group within PDS&T is looking for a contractor to support method development, robustness, and validation studies. Additional laboratory testing to be assigned as appropriate.
US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com.
US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.