Analyst Jr. Group Leader - Bioanalytical Research

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 New 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 opportunity

Professional skills :

• Problem Solving Skills
• Leadership
• People Management