Role & responsibilities

Perform Analysis :
Lead the team along with GL or in absence of GL
Design the experiment for development
Resource planning skills and shift and manpower planning and coordination
Special bioanalytical techniques- Peptide, Liposomal method handling
Endogenously present molecule handling and Approach
Rare matrix (Aqueous Humour, Skin, tissue etc)handling conceptual clarity
failure handling and resolution skills
coordinate with SGL for targets alignment and execution
target achievement as team
LC and LC/MS- calibration
Perform analysis via LCMS. Follow GxP
Work pressure effective handling skills

Documentation and compliance :
Preparation of Method SOP, Method validation protocol and Bioanalytical study plan
Awareness of various sponsor and regulatory requirement for protocol preparation
coordination with SGL, QC, RW and QA for response to query and observation
the regulatory and sponsor communication during audit
Supervise and verify online documentation of development trial in Method Book (Laboratory Record Book), validation experiment documentations, entry in log books in control forms as per SOP,



evaluate experiment out-come with pre-defined validation/Study protocol
Document all linked activities and forms as per SOP.

Research & Development :
Literature review i.e. published pharmacopeia guidelines/research documents received from GL and SGL.
Optimize the equipment (Mass Spectrometer) & Chromatography parameters (Analytical Column) for specific analyte (Drug sample), perform extraction trials by using blank matrix and finalize method for validation.
Validation: Perform experiments as per protocol
Presentation and publication opportunity
preparation of Recent SOPs and processes special techniques - Micro capillary, SFC, ICP-OES handling

Equipment Calibration :
LC and LC/MS- calibration
Train analyst for various calibration activity and verify the calibration record documented by analyst

Training:
To coordinate assist/support in on-the-job trainings for fresher
Training of team
Presentation and publication prospect

Qualified skills :
Problem Solving Skills
Leadership
People Management

📌 Analyst Jr Group Leader Bioanalytical Research Ahmedabad (India)
🏢 Veeda CR
📍 India