Analytical R&D | Biological E | Hyderabad

Job Description

Designation: Executive/ Sr Executive

Department: Analytical R&D

Educational Qualification: M.Pharm/ M.Sc (Lifesciences)

Experience: 2-6 yrs

Key Responsibilities:

• Candidate should have a good understanding of Analytical / Bioanalytical method development, qualification, and validation including stability.
• Experimental design – select and/or develop analytical methodology following literature review and discussion with the supervisor as required.
• Candidates must be independent and able to proactively apply their knowledge in the design, execution, and qualification of analytical methodologies. They will also play an important role in the technology transfer of established methods to QC.
• Preparing STPs, SOPs, and protocols for analytical methods and instruments.
• Expertise in handling various chromatographic and spectroscopic instruments.
• Development of biochemical assays for various polysaccharides, polysaccharide-proteins conjugates and proteins.
• An understanding of the regulatory environment, particularly ICH, CDSCO and EMA guidelines on analytical method development and validation would be an advantage.

Documentation

• Authorship of SOPs, study reports, and protocols.
• Write up laboratory notebooks regularly in compliance.
• Preparation of presentation as needed by supervisor.

Candidate skill set required:

Technical / Functional:

• Analytical method development for biomolecules.
• Should have hands-on experience in gel electrophoresis and blotting techniques.

Knowledge:

• Method development and qualification experience with a primary focus on the characterization of proteins, conjugates, or other biologics inconsistent with standard regulatory guidelines using Chromatography,
• Biochemical assays, and Spectroscopic techniques