Job Description

Summary The Senior Research Associate will perform a variety of analytical methods in support of product characterization and method development. The Senior Research Associate will design and executes laboratory experiments with a high degree of independence and troubleshoot unexpected experimental outcomes. He/she will also perform GMP testing as required in support of release and stability of API and finished drug product and contribute to maintaining a clean and safe laboratory environment.  Essential Functions ·       Participate in development, qualification, and validation of protein characterization assays, such as RP-HPLC, SEC-HPLC, AEX-HPLC, SDS-PAGE, Western blot, BCA, etc. ·       Perform compendial methods such as pH, conductivity, osmolarity, etc. ·       Routine analysis of in-process and release samples ·       Perform routine maintenance, calibration and qualification of laboratory equipment and instrumentation ·       Write, revise, and maintain assay SOPs and worksheets, protocols, reports, instrument SOPs, and other documentation as needed ·       Assist in maintaining inventories of chemicals, reagents, and reference materials ·       Close attention to detail and the ability to multitask ·       Analysis and interpretation of test results, identify deviations, and make appropriate recommendations ·       Present data within the Analytical Development group   Minimum Education, Experience, Skills ·       Bachelor’s Degree in Chemistry or closely related scientific discipline with at least 5 years of relevant experience. ·       Knowledge of and hands-on experience with HPLC methods; familiar with either Waters or Thermo HPLC system and their HPLC data process software such as Empower and/or Chromeleon; some Mass Spec experience is a plus. ·       Ability to follow SOPs and comply with cGMPs; generate SOPs ·       Possess a strong work ethic along with a solid organizational, time management, problem-solving, and interpersonal skills Demonstrated experience analyzing critical data and proactively solving problems ·       Excellent written and verbal communication skills ·       Good understanding of regulatory requirements, including FDA/EMA, GMP, ICH, USP/EP ·       Ability to work with a high level of independence to design, troubleshoot, and execute experiments ·       Experience working independently and thriving in a fast-paced environment ·       Basic computer skills, including MS Word, Excel, PowerPoint ·       Able to learn new skills quickly