Junior Group Leader

8 hours ago

Ahmedabad, Gujarat, India Veeda CR Full time ₹ 6,00,000 - ₹ 18,00,000 per year

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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