10 Aug
|
PI Health Sciences
|
Hyderabad
10 Aug
PI Health Sciences
Hyderabad
Summary Role
We are looking for an experienced Bioanalyst with around 5 years of hands‑on experience in ADME and DMPK sample analysis, along with supporting pharmacology studies. The role involves sample preparation, LC‑MS/MS operation, data processing, documentation, and coordination with cross‑functional teams.
Key Responsibilities:
- Perform in‑vitro ADME assays such as Metabolic Stability, Plasma Protein Binding (PPB), PAMPA, Solubility, CYP inhibition/induction, etc.
- Support in‑vivo DMPK studies by handling PK sample preparation and analysis.
- Operate and maintain LC‑MS/MS 6500 systems for routine and study‑based sample analysis.
- Prepare calibration curves, QC samples, and process batches as per study requirements.
- Process, review, and compile analytical data with high accuracy.
- Support basic pharmacology studies (e.g., biomarker assays, sample processing, ELISA-based readouts if applicable).
- Ensure proper documentation in lab notebooks, worksheets, and data sheets.
- Follow lab SOPs and maintain compliance with internal quality systems.
- Coordinate with study leads, project managers, and team members to meet timelines.
- Troubleshoot routine instrument issues and escalate when needed.
- Maintain sample inventory, reagents, and consumables related to ADME/DMPK studies.
Required Skills:
- Solid experience in LC‑MS/MS‑based bioanalysis
- Hands‑on expertise with in‑vitro ADME assays
- Positive understanding of PK workflows and data interpretation
- Ability to follow SOPs and generate accurate data
- Basic troubleshooting skills for LC‑MS/MS instruments
- Good communication and team‑coordination skills
- Familiarity with regulatory expectations for non‑GLP fit‑for‑purpose studies
Preferred (Optional):
- Experience with software such as Analyst, WinNonlin, CDD, or similar data‑processing tools
- Exposure to invitro ADME studies.
- Understanding of ICH/M10 expectations (not mandatory, but beneficial)
Educational Qualification : M. Pharma / M.Sc./Ph.D in Analysis or Pharmacology, Pharmaceutical Sciences, or a related discipline.
Experience: 5–7 years of experience with exposure to independent bioanalysis and data interpretation, Clean sample preparations for all ADME and PK studies.
📌 Team Lead - Bioanalysis/ Bioanalytical (Hyderabad)
🏢 PI Health Sciences
📍 Hyderabad