Medicilon USA Corp is seeking a motivated and detail-oriented Research Associate to join our DMPK and Bioanalysis team in Lexington, MA. This is a hands-on laboratory role supporting preclinical drug discovery and development, with a primary focus on bioanalytical sample preparation, LC-MS/MS, and quantitative analysis.
The ideal candidate will have practical experience in analytical chemistry, bioanalysis, or DMPK, with a strong understanding of laboratory techniques and biological sample processing. This individual will work closely with Scientists and cross-functional teams to support pharmacokinetic (PK), toxicokinetic (TK), pharmacodynamic (PD), biomarker, and biodistribution studies across multiple therapeutic modalities.
Key Responsibilities
- Perform bioanalytical sample preparation and quantitative analysis of biological matrices, including plasma, serum, urine, and tissue samples.
- Support LC-MS/MS method development, optimization, and analysis of small molecules, biologics, oligonucleotides, and other therapeutic modalities.
- Perform sample preparation techniques, including protein precipitation, liquid-liquid extraction, and solid-phase extraction (SPE).
- Prepare calibration standards, quality control samples, reagents, and study samples.
- Operate, maintain, and troubleshoot LC-MS/MS, HPLC, and other analytical laboratory instruments.
- Process, analyze, and summarize experimental data using Analyst, Excel, GraphPad Prism, or other relevant software.
- Support bioanalytical studies for PK, TK, PD, biomarkers, and biodistribution.
- Assist with additional bioanalytical platforms, including ELISA/MSD, ligand-binding assays, qPCR/ddPCR, and cell-based assays, as needed.
- Support in vitro ADME assays, including metabolic stability, plasma protein binding, permeability, and drug-drug interaction (DDI) studies.
- Maintain accurate laboratory records and documentation in accordance with established SOPs, study protocols, and applicable GLP/GxP requirements.
- Assist with data interpretation, study reports, and technical documentation.
- Collaborate with Scientists and project teams to ensure accurate, efficient, and timely study execution.
Qualifications
- Bachelor's or Master's degree in Analytical Chemistry, Chemistry, Biochemistry, Pharmaceutical Sciences, Pharmacology, Biology, or a related field.
- 1–3 years of relevant laboratory experience in bioanalysis, analytical chemistry, DMPK, pharmaceutical research, or a related field.
- Hands-on experience with LC-MS/MS and/or HPLC instrumentation.
- Experience with biological sample preparation and processing, including plasma, serum, urine, or tissue samples.
- Understanding of chromatographic techniques, mass spectrometry, and quantitative bioanalytical methods.
- Familiarity with laboratory data analysis, documentation, and quality control procedures.
- Strong attention to detail, organizational skills, and ability to follow established experimental protocols and SOPs.
- Good communication, problem-solving, and teamwork skills.
- Ability to work independently on assigned laboratory tasks while collaborating effectively with a multidisciplinary team.
Preferred Qualifications
- Previous experience in a CRO, pharmaceutical, or biotechnology laboratory environment.
- Experience with LC-MS/MS method development, optimization, qualification, or validation.
- Experience with bioanalysis of small molecules, oligonucleotides, biologics, or other novel therapeutic modalities.
- Familiarity with ELISA/MSD, ligand-binding assays, qPCR/ddPCR, or cell-based assays.
- Knowledge of GLP principles and FDA/EMA bioanalytical method validation guidelines.
- Experience with in vitro ADME assays or PK data analysis using Phoenix WinNonlin.
- Hands-on experience supporting in vivo rodent studies, including animal handling, compound dosing, blood collection, necropsy, and tissue harvesting.
- Experience processing biological samples collected from in vivo studies for downstream bioanalytical analysis.