Job Description

Job Description:

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 Client 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.
Responsibilities :

• Develop, optimize, and validate analytical methods for protein-based biologics.
• Conduct separation techniques, including HPLC (SEC, IEX, HIC) and capillary electrophoresis.
• Perform routine laboratory tasks such as sample preparation, weighing, pipetting, pH measurement, and solution preparation.
• Maintain accurate laboratory records in compliance with Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).
• Analyze and interpret data, troubleshoot analytical methods, and support commercial formulation and process development studies.
• Collaborate with cross-functional teams to ensure robust analytical methods for commercial QC labs.
• Support clinical supplies release testing and stability studies.

Qualifications

Requirements:

• BS in Chemistry (or similar field) with 3 to 5 years lab experience or a master’s degree with 0 years of experience.
• Practical experience and knowledge of protein HPLC (e.g., SEC, IEX, HIC), capillary electrophoresis, and other separation techniques as applied to protein analysis preferred.
• 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 required.
• Independent understanding and execution of established methods and techniques including operation of the relevant software required.
• Ability to multitask and work within timelines preferred.

Additional Information

Physical Demand:

While performing the duties of this job, the employee is regularly required to stand, walk, and sit for extended periods of time. Occasionally the employee may be required to lift or move at least 20 pounds. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.