
Junior Group Leader
3 days ago
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
Preferred candidate profile:
- Education: B.Pharm, M.Pharm, M.Sc
- Experience: 3-8 Years' experience in CRO.
Professional skills:
- Problem Solving Skills
- Leadership
- People Management
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