Research Scientist (Sample Analysis) - Bioanalytical Dept

QPS, LLC•Newark, DE

9h•Onsite

About The Position

QPS, LLC has an opening for a Research Scientist in our Bioanalytical (GBA) department. GBA is comprised of three laboratory operation units: Small Molecules, Proteins, and Oligonucleotides, and each unit has their own Method Development/Method Validation/Sample Analysis (MD/MV/SA) group. In this role, you will play a pivotal part in QPS’ continued expansion of our bioanalytical capabilities to support drug development of small molecules, antibody drug conjugate, protein, and genetic medicines. The GBA department expertise lies in the quantitation of small molecules, peptides, proteins, oligonucleotides, and biomarkers by various chromatographic (standard flow LC, microflow LC, SFC) couple to tandem mass spectrometric (MS/MS, MS/HRMS, hybrid/immunocapture mass spec) techniques. We have been pivotal in supporting most of the HIV drugs, most of the HBV/HCV drugs, 2 of the 15 ADCs, and 7 of the 24 oligonucleotides therapeutics approved by FDA/EMA. We are currently looking for Research Scientists for our Sample Analysis groups. This position will serve as Principal Investigator (PI) on Bioanalytical studies and be responsible for study management, interpretation and reporting of study data, and in concert with team members and peers, will participate in method validation when needed.

Requirements

Ph.D. degree
Recent graduates must have with direct experience on LC-MS/MS analysis
If more than 2 years since graduation, candidates must have direct experience on method development of bioanalytical assays using LC-MS/MS, particularly having CRO experience
Understanding of experimental design and planning, and data collection and analysis software.

Responsibilities

Independently manage multiple sample analysis projects/studies at the same time with minimum supervision.
Prepare, and/or review and understand study protocols.
Coordinate with client and internal resources to plan, design and conduct studies.
Evaluate significance of data and report findings.
Prepare Study summaries and/or reports.
Set-up, utilize, and maintain complex instrumentation.
Communicate project timelines, status, data, reports, and inquiries to client and/or study sites, effectively addressing any issues that may arise.
Maintain the proper level of regulatory compliance for each study, preparing QA related documents and addressing QA audit findings.
Maintain schedule of projects and timelines.
Supervise, train and/or mentor junior scientific staff.
Develop, validate and run sensitive, reliable and efficient LC/MS/MS assays for TK/PK assessment.
Ensure that GLP regulations and SOPs are followed in all bioanalytical service activities.