·         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.

Key Responsibilities and Qualifications:

·         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.

What are the top 3-5 skills, experience or education required for this position:

·         BS in Chemistry (or related field) 3 to 5 yrs lab experience, or a Master’s Degree.

·         Experience with good laboratory/manufacture practices preferred.

·         Experience with separation techniques (HPLC, capillary electrophoresis, etc.) preferred.

·         Experience with biologics (i.e., proteins, etc.) preferred.

·         Ability to multitask and work within timelines preferred.