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
Click
here to apply!
|