Sr. Associate, Analytical Development

Company: BioPhase Solutions
Location: San Diego
Posted on: May 16, 2022

Job Description:

Job DescriptionJOB SUMMARY The Senior Associate will perform a variety of analytical test methods for release and stability of API and finished drug product. The Senior Associate will execute laboratory test procedures with a high degree of independence and troubleshoot unexpected outcomes. He/she will contribute to maintaining a clean and safe laboratory environment. ESSENTIAL FUNCTIONS Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions. • Perform protein characterization assays such as RP-HPLC, SEC-HPLC, AEX-HPLC, SDS-PAGE and BCA •Perform compendial methods such as pH, conductivity and osmolarity • Routine analysis of in-process, release and stability samples following cGMP/cGDP. • 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 • Maintain inventories of chemicals, reagents, and reference materials • Attention to detail and the ability to multitask • Analysis and interpretation of test results, and initiation of deviations/OOS/OOT reports as required 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 cGxP; 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

Keywords: BioPhase Solutions, San Diego , Sr. Associate, Analytical Development, Other , San Diego, California