5+

Review of Literature and patents and preparation of Pre-product development strategy. Execution of experimental work and reporting of observations. Compilation of pre-formulation data on the drugs and excipients used in the formulations. 

Monitoring and ensuring timely completion of GLP studies. Impurity profiling - structure elucidation of unknown impurities. Supporting the team to develop the methods on HPLC, GC, IC, ICP-MS, GC-MSMS and LC-MSMS

Biocon Biologics is driven by a strong sense of purpose and the unwavering commitment to serve patients and healthcare systems across the globe by unlocking equitable access to high quality biosimilars.

Patent search, literature search, Pre formulation study, Formulation optimization with QBD approach. Scale up at plant level.

Experience into Complex Injectable and Complex Equipment like HPH, Isolator, Wet Mill, ANFD. Experience in injectable and Ophthalmic dosage form like suspension & Gel forming and simple ophthalmic range.

Accuprec Research Labs Pvt Ltd. is FDCA approved, OECD-GLP, NABL accredited and ISO 9001:2015 certified CRO. Head Quarter of the CRO is located at Ahmedabad and branch offices at Canada and USA.

Strong knowledge of GMP, GDP, and regulatory compliance for pharmaceutical warehousing. Exposure of various instruments/ software like empower 3, LIMS and other software.

Candidate should be well versed with operation and maintenance of ointment manufacturing plant and handling PLC, SCADA. Handling of tube filling activity and packing activity of ointment, creams, lotions.

Exposure to OSD Manufacturing operations like Granulation, Compression, Pellet coaling, Capsule filling, Primary Packing & Secondary Packing. Expertise in e-BPR and e-log will he added advantage. Experience of HPLC, UV spectrophotometer and Dissolution Tester operation. Experience of Analytical Method Validation/Transfer. Experience of GC, ICPMS and/or LCMS operation.