Biological E. Limited Jobs – Life Sciences Apply Online
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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