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 and 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
Training
Train analyst for various calibration activity and verify the calibration record documented by analyst.
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
Job Types: Full-time, Permanent
Pay: ₹600,000.00 - ₹800,000.00 per year
Benefits:
Food provided
Health insurance
Leave encashment
Paid sick time
Provident Fund
Education:
Bachelor's (Required)
Work Location: In person
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