Scientist Grade III

NIB NATIONAL INSTITUTE OF BIOLOGICALS

(Ministry of Health & Family Welfare, Govt. of India) A-32, Sector – 62, Institutional Area Phase-II,

NOIDA – 201309, U.P

The National Institute of Biologicals, an autonomous Institute under the Ministry of Health & Family Welfare, Government of India, is a premier Scientific Organization and a Centre of Excellence to ensure quality of vaccines and biologicals in the country. Applications are invited for the following posts on direct recruitment basis:

1. Scientist Grade III – 6 Posts

Essential:

A. Medical (Essential):

i) PG Medical degree in the field of Microbiology/Biochemistry/ Immunohaematology & Blood Transfusion / Pharmacology/ Bacteriology / Serology / Hematology from the recognized University and

ii) One year experience in the field after acquiring the essential qualification

B. Non Medical (Essential)

i) M. Sc in Microbiology / Clinical Microbiology / Biotechnology/ Bioinformatics/ Biochemistry / Bacteriology / Physiology/ from any recognized University with at least 60% marks. and

ii) A minimum of three years’ of relevant experience in any of the following areas:

a) Quality Control Testing of Biologicals and Biotherapeutics;

b) Review of Technical Dossiers of Biologicals and Biotherapeutics including Vaccines in respect of Chemistry Manufacturing Control (CMC), non-clinical trial data on Animal Pharmacology/Animal Toxicology, Clinical Trial data;

c) Review of Technical Dossiers of ‘In Vitro Diagnostic (IVD) Medical Devices’ in respect of conformation to the Essential Principles of Safety and Performance of Medical Devices which include Product Description, Design and Manufacturing information, Product performance specifications and associated validation and verification studies, Labelling and Regulatory history;

d) Evaluation & Review of Adverse Events:

i) following Immunization (AEFI)

ii) associated with Biologicals and Biotherapeutics (Pharmacovigilance)

iii) associated with blood transfusion and blood products administration (Haemovigilance);

iv) due to indirect harm associated with IVD Medical Devices (Materiovigilance)

e) Management of Quality System with application of ISO: 17025 and ISO : 34 with Total Quality Management approach .

f) Research in Biologicals and Biotherapeutics,

Desirable: At least 2 (two) publications or Articles in Indexed Journals, in any of the above mentioned fields of qualification or experience.

2.Jr. Scientist – 7 Posts

Essential:

i) M.Sc. in Microbiology / Clinical Microbiology / Biotechnology/ Bioinformatics/ Biochemistry /Pharmacology/ Serology / Molecular Biology/Physiology from any recognized University with at least 60% marks. and

ii) A minimum of one year’s of relevant experience in any of the following areas:

a) Quality Control Testing of Biologicals and Biotherapeutics;

b) Review of Technical Dossiers of Biologicals and Biotherapeutics including Vaccines in respect of Chemistry Manufacturing Control (CMC), non-clinical trial data on Animal Pharmacology/Animal Toxicology, Clinical Trial data;

c) Review of Technical Dossiers of ‘In Vitro Diagnostic (IVD) Medical Devices’ in respect of conformation to the Essential Principles of Safety and Performance of Medical Devices which include Product Description, Design and Manufacturing information, Product performance specifications and associated validation and verification studies, Labelling and Regulatory history;

d) Evaluation & Review of Adverse Events:

i) following Immunization (AEFI)

ii) associated with Biologicals and Biotherapeutics (Pharmacovigilance)

iii) associated with blood transfusion and blood products administration (Haemovigilance);

iv) due to indirect harm associated with IVD Medical Devices (Materiovigilance)

e) Management of Quality System with application of ISO : 17025 and ISO : 34 with Total Quality Management approach .

f) Research in Biologicals and Biotherapeutics

Desirable: At least 1 publication or an Article in an Indexed Journal in any of the above mentioned fields of qualification or experience.

The last date for submission of complete application form is 01.07.2015 upto 05.30 p.m. Incomplete applications or applications received after the last date will not be entertained.