Associate Scientist

9 hours ago

Pune RD MH IN lupin ltd Full time ₹ 8,00,000 - ₹ 12,00,000 per year

Associate Scientist - Pharma Research OOD Job Description 1> Design and development prototype lab scale ANDA/ generic formulations for regulated markets & all associated documentation. 2>Carry out pre-formulation and formulation development experiments for new chemical entities and ANDA formulations. 3> Planning & execution of QbD documentation and experimental studies 4>Prepare stability protocols and collect the stability data as per ICH guidelines. Set specifications for In process and finished products as per ICH. Organize tech transfer of developed products to plants for the manufacturing of scale up, exhibit, clinical or bio study batches. 5> Execution of scale-up/ exhibit batch & preparation of necessary documentation for filing. Interact with Cross functional teams like process development, QC, QA, Regulatory, etc for successful development and technology transfer of new products. 6> Data compilation and preparation of product development report. 7> Give timely support in resolving regulatory queries. 8> Review bio study and clinical study designs and protocols. Analyze and interpret significance of bio/clinical study results. 9>Maintain inventory and reconciliation of Innovator products. Maintenance and up keeping of the lab and pilot areas. Maintain and follow safety standards as issued by the Company. Follow existing or prepare new SOPs and equipment operating procedures Work Experience >1-4 years Education MastersDoctorate in Pharmaceutical Technology Competencies CollaborationCustomer CentricityDeveloping TalentInnovation & CreativityProcess ExcellenceResult OrientationStakeholder ManagementStrategic Agility Experience LevelMid Level

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