Biological E - DM/Manager - Analytical Development

Manager/Dy.Manager - Analytical Development (in-vivo testing)

Academic Background and Experience:

MVSc/BVSc/Msc/M.Pharmacy

8 to 12 years- experience in in-vivo testing of Human vaccines

Purpose: To manage a team of 8 in in-vivo testing of combination vaccines (D, P, T, HepB, Hib & IPV) and support PCT studies with CRO for Developmental products

Job responsibilities:

- To maintain the Animal house facility.

- To handle Swiss albino, Balbc & Guinea pigs for testing.

- To plan and execute in-vivo testing of Developmental batches.

- Planning and procurement of animals for testing.

- Monitoring scientist for PCT study on Developmental products.

Operating Network

Internal: Formulation development, Quality control & DQA

External: Bioneeds for PCT studies, Clintox for developmental vaccine testing & Animals supplier

Technical Requirements:

- Invivo Potency test on Diphtheria, Tetanus, Pertussis, and Hepatitis B & Hib.

- Specific toxicity of Diphtheria & Tetanus

- Mouse weight gain test on Pertussis

- Determination of LD-50 units.

- Irreversibility test of Diphtheria & Tetanus

- Abnormal toxicity test

- Design & execution of preclinical toxicology study

- Raising hyper immune serum in animals

- Should have subject knowledge on CPSEA, OECD, WHO guideline

Key personal competencies: Animal inoculations both laboratory animals and large animals, experience in handling bacteria and viruses, Fair understanding of immunology and toxicology, Good documentation & communication.