As a part of the Hetero Group, our Biologics vertical, comes with a rich legacy - Proven capabilities in the development, manufacturing and marketing of chemical intermediates, APIs, ARVs and Finished Dosage Formulations. With leadership in chemical therapeutics, Hetero continues to lead from the front in the development and manufacturing of Biopharmaceuticals using novel technologies. Hetero has 36 state-of-the-art manufacturing facilities strategically located worldwide. And a majority of our facilities have been successfully audited and approved by stringent regulatory authorities like US FDA, EU, TGA-Australia, MCC-South Africa and others.
Post : Manager / Sr. Manager
Job Responsibilities :
1. Build, lead and develop a team with expertise in the area of upstream cell culture process.
2. Provide technical inputs and oversee all the R&D upstream activities from R7d cell bank preparations to Commercial validations
3. Scale-up exposure and technology transfer experience is desired along with trouble shootings at large scale operations.
4. Should prepare protocols and reports of various studies performed in R&D.
5. Manage. Analyze and interpret data sets of all upstream operations from R&D to commercial scale implementation.
6. Should have a sound knowledge on data analytical software such as JMP . MATLAB etc..
7. Should be able to implement the QbD based process development through DOE based product development.
8. Should be able to prepare Risk assessments for raw materials, process and other relevant activities.
9. Should participated in writing the upstream CMC section of the dossiers of various markets.
10. Able to train the team with constructive feedback and good negotiation skills.
11. Good English writing and reading skills are desired along with scientific reading of articles and journals.
12. Follow up and completion of Calibration and Preventive maintenance of the cell culture equipment.
Experience : 9-14 years
Department : Upstream Process (R&D)
Location : Jadcherla (Telangana)
Industry Type : BioPharma
End Date : 30th June, 2020
Interested candidates can send their resume to email@example.com
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