Experience with laboratory notebooks in compliance with Good Laboratory/Manufacturing Practices would ideal.
Independent understanding and execution of established methods and techniques, including operation of the relevant software, once training is complete
Ability to multitask and work within timelines
Description:
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 diverse pipeline of innovative therapeutic biologics medicines, including monoclonal antibodies, antibody drug conjugates (ADC), and other novel 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&Ts 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 laboratory activities and routine testing. Additional laboratory testing to be assigned as appropriate. Associated training will be provided.
