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Biological E. Limited Job Opportunity

Location: Shamirpet, Hyderabad

Position: Executive / Sr. Executive

Qualification: B. Tech/ MTech/ M.Sc (Life Sciences)

Experience: 3 to 6 years

Job Description:

  • Execute and manage pre-formulation and formulation development activities for various vaccine products with sound knowledge of aseptic process handling and analytical techniques thereof.
  • Provide subject matter expertise on aseptic liquid and lyophilization applications.
  • Conduct literature and patent searches as and when required. Must have knowledge and understanding of current regulatory guidelines of WHO, CDSCO, ICH, FDA, EMEA, etc. Must have a good understanding of cGMP/GLP compliance requirements.

Must have hands-on experience of:

  • Bench-top and commercial-scale lyophilizer with in-depth knowledge about Lyophilization cycle development.
  • Microfluidizer, High-pressure homogenizer, Rotary evaporator, Tangential flow filtration, DLS, Microscopy.
  • Conducting stability studies, stability data compilation, and evaluation.
  • Routine lab management, Procurement, and Inventory Control of the materials and consumables required for day-to-day activities.
  • Selection and procurement of process-related instruments and equipment.
  • Ensure and upkeep the qualification/Calibration and maintenance of the equipment and instruments from time to time.

Must have detailed knowledge and experience of GMP documentation for:

  • Preparation of SOPs, Study Designs, Study Protocols, BPRs, BMRs, MFCs, Study Reports, Stability Protocols, and Stability reports, etc. as per requirements.
  • Updating Lab Notebooks with complete experimental data.
  • Recording and maintenance of Equipment log books as per respective SOPs.
  • Initiation of change controls.
  • Ensuring good document practices as per GMP/GLP and compliance as per regulatory norms.

How to Apply:

Interested candidates with the relevant experience can send their updated CV to [email protected] and [email protected].

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