Jr. Group Leader

Department: Bioanalytical Research

Primary Responsibility

Description

• Perform Analysis
• Documentation and compliance
• Research & Development
• Equipment Calibration
• Training
• Professional skills

Responsibilities

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 a 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 requirements for protocol preparation. Coordination with SGL QC RW and QA for response to query and observation. Regulatory and sponsor communication during an 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 outcome 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 analysts for various calibration activities and verify the calibration record documented by analysts.

Training

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

Professional skills

• Problem Solving Skills
• Leadership
• People Management