Our global team is made up of a diverse group of professionals committed to serving the needs of our 30,000 clients around the globe. Our culture’s core values consist of respect, integrity, accountability, communication, and quality. We operate in a fast-paced environment that, while in operation for over 30 years, maintains an entrepreneurial spirit and a “can do” attitude.
Responsibilities
Develop, implement, and routinely perform analytical sample preparation workflows for HPLC, LCMS and MS for quantifying and characterizing metabolites derived from hepatocytes.
Perform Analytical assays and automation as needed.
Assist with sample processing, quality control, process improvement, equipment maintenance, proficiency/competency training standards and schedules.
Apply state-of-art mass spectrometry instrumentation for developing and validating quantitative LC-MS/MS methods.
Standardize methods across various BioIVT sites and perform validation studies.
Implement global BioIVT best practices of analytical testing at the Baltimore site.
Develop sample preparation and bioanalytical assays for characterization.
Ensure all analytical laboratory documents are completed within specified timelines.
Write equipment Discrepancy/Deviation Reports, OOT’s, OOS’s. Accurately maintain appropriate quality control files and QC databases.
Work with manager to conduct laboratory investigations related to product testing.
Prepare release documentation (Product Data Sheets/Certificates of Analysis) as required.
Perform data analysis, collaborate with customers, R&D and other scientific and quality teams
Demonstrate competency in troubleshooting, optimization, and implementation of challenging and innovative LC-MS/MS assays.
Contribute to validation/qualification protocols and reports, bioanalytical reports, etc., as appropriate.
Train other QC analysts and serve as SME.
Comply with established laboratory regulations, standards, policies, protocols, processes, procedures, and plans. Adapt to changes in these regulations and standards as they are announced
Qualifications
Required qualifications for this position includes:
Bachelor’s Degree -OR- Master’s Degree in Chemistry, Biochemistry, Chemical Engineering, or Biology -OR- Five (5) years of equivalent professional experience in lieu of Master’s Degree
Significant analytical instrumentation experience
Knowledgeable about hepatocytes, molecular biology, and genomics
Two (2) years of experience related to HPLC and/or MS methods development in a clinical laboratory or experience in academia, biotechnology, or other healthcare field Experience in ADME Tox Induction and cell-based studies
Excellent knowledge of standard analytical laboratory equipment, instrumentation, and associated software.
Experience in ADME Tox Induction and cell-based studies
Microsoft Excel, Word, and Outlook
Extensive knowledge of instrumentation methods development
Experience with aseptic technique and general laboratory practices
Experience with the proper use of chemical and/or biohazardous materials
First-hand experience working with cross-functional or cross-site teams for implementation of best practices in analytical laboratory.
Proven experience and success in a team-oriented environment
Proven success in independent effort and delivering high quality data with biological relevance in a team environment
PHYSICAL DEMANDS:
Position requires sitting and/or standing for long periods of time
Ability to lift up to 25 pounds
Ability to work in a fast-paced environment and meet time and quality-based objectives
WORKING CONDITIONS:
Occasionally required to work longer hours
Contact with biological specimens and sharps daily
We offer a comprehensive benefit package for eligible team members including medical, dental, vision, short-term/long-term disability, life insurance, hospital indemnity and accident insurance. We also offer a generous retirement plan with a company match. Eligible employees also enjoy competitive time-off policies. We are a collaborative environment that promotes growth from within. Enjoy company-sponsored events for the entire team!
We can’t wait to work with you!
We are an equal opportunity employer.
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