Biological E Limited Hiring For R&D Formulation Development
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Biological E Limited Hiring For R&D Formulation Development |
Biological E. Limited is hiring for R&D Formulation Development preformulation vaccines Shamirpet location, Hyderabad.
Position: Executive / Sr. Executive
Qualification: B. Tech/ MTech/ M.Sc (Lifesciences)
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.
Literature and Patent search as and when required.
Must have knowledge and understanding of current regulatory guidelines of WHO, CDSCO, ICH, FDA, EMEA, etc.
Must have 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's.
To ensure and upkeep the qualification/Calibration and maintenance of the equipment and instruments 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 time to time as per requirements.
Updating Lab Note books 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.
Interested candidate with the relevant experience, can send their updated CV Gopinath.Kandela@Biologicale.com, Careers@biologicale.com
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's.
To ensure and upkeep the qualification/Calibration and maintenance of the equipment and instruments 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 time to time as per requirements.
Updating Lab Note books 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.
Interested candidate with the relevant experience, can send their updated CV Gopinath.Kandela@Biologicale.com, Careers@biologicale.com
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