Duration: 12 months (With Potential Extension)
Work Schedule:
- M-F, 40 hours 1st shift, OT offered when needed
Description:
- Client’s Product Development Science and Technology (PDS&T), Analytical Development - Lake County is a global analytical sciences organization responsible for all CMC analytical activities related to the development of Client’s therapeutic biologic products. Our scope includes Client’s diverse pipeline of innovative therapeutic biologics medicines, including monoclonal antibodies, antibody drug conjugates (Client), and other Client 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 laboratory activities and routine testing. Additional laboratory testing to be assigned as appropriate. Associated training will be provided.
Skills:
- Experience with routine laboratory activities (e.g., sample preparation, weighing, pipetting, pH measurement, solution preparation, etc.) preferred.
- Ability to maintain a laboratory notebook in compliance with Good Laboratory/Manufacturing Practices preferred.
- Independent understanding and execution of established methods and techniques including operation of the relevant software required once training is complete.
- Ability to multitask and work within timelines required.
Education and experience:
- BS in Chemistry (or similar field) 0-2 years of experience.
About US Tech Solutions:
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.
Contact Details:
Name: Shivangi Shivpuri
Email: shivangi.s@ustechsolutionsinc.com
Internal Id: 26-07931
