Company: Biocon Limited
Qualification: M.PharmaExperience: 12 - 18 years
Role Summary
(1) Candidate should be leading a group of scientists who will be responsible for Drug product formulation development activities including filter validation, extractables and leachables for Recombinant therapeutics.
(2) Managing and nurturing the team
(3) Person sould be accountable for assigned deliverables for the projects.
(2)Design studies for the development of drug products Process characterization, Formulation characetrization including various types of stability studies
(3)Interpretation (including statistics) of data generated, preparing presentations for project meetings and presenting data to seniors managements
(4)Data analysis and understanding trends in data generated, report writing and review, authoring sections for regulatory submissions, risk assessments
(5)Extensive involvement in tech transfer activities to manufacturing/partners/CROs and following the performance of the manufacturing process, including troubleshooting
(6)Involvement in vendor selection, evaluation, legal and IPR documentation, EHS activities and any ad-hoc trainings as required by the Company; discussions with external consultants
Key Responsibilities
(1)Design studies for the development of drug products Process characterization, Formulation characetrization including various types of stability studies
(2)Interpretation (including statistics) of data generated, preparing presentations for project meetings and presenting data to seniors managements
(3)Data analysis and understanding trends in data generated, report writing and review, authoring sections for regulatory submissions, risk assessments
(4)Extensive involvement in tech transfer activities to manufacturing/partners/CROs and following the performance of the manufacturing process, including troubleshooting
(5)Involvement in vendor selection, evaluation, legal and IPR documentation, EHS activities and any ad-hoc trainings as required by the Company; discussions with external consultants
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