Head Biotech R&D Process Devp- Pharma /biotech -Aurangabad

Role & responsibilities

Candidate will be based at Pharma Biotech R&D Center at Aurangabad and will Head R&D for

Domestic & International Markets with focus on upstream / downstream process

Development for bio -similar therapeutic proteins, preferably Insulin, Insulin analogues and or other biologics using E. coli, yeast and/mammalian cell culture.

1. Candidate will Responsible for designing the R&D Strategy of the organization especially for

Process development with scientists and guide the team members for bio-similar non-infringing

process development.

2. Candidate will be responsible for upstream and downstream process development using microbial

and mammalian platforms. Experience of bio similar drug substance process development, scale

down model qualification and process characterization particularly of Insulin and Insulin analogues is

highly desirable.

3. Candidate will be responsible Drug substance process development, scale down model

qualification and process characterization to meet the Domestic and international regulatory Market

requirements.

4. Candidate will be experience in process development and process characterization using QbD

approach.

5. Candidate will be responsible regulatory filings to RCGM/DCGI/CDSCO for preclinical and clinical

studies approval and manufacturing of clinical trials material.

6. Candidate will responsible for actively participate in obtaining patents for products, processes, or

equipment.

Preferred candidate profile

1. Candidate should be Masters in pharmaceutical in Pharmaceuticals and with 15 + years

experience in R&D Process development of experience of upstream/ downstream process

Development for bio similar therapeutic proteins, preferably Insulin, Insulin analogues and or other biologics using E.coli, yeast and mammalian cell culture.

2. Candidate should have a skills building and maintaining productive relationships with

Organizational partners including team work.

3.Candidate should have handle Technology transfer, technology assessment at partner site, vendor evaluation, training, workshops, conferences.

4.Candidate should have coordinate with Technology transfer, technology assessment at partner site, vendor evaluation, training, workshops, conferences.

5. You should have Effective communication with internal and external customers to complete projects successfully within target timelines.

6.You should have good Understanding of project criticality with respect to business needs