Recruitment at Cisen Pharmaceutical India
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Cisen Pharmaceuticals - Formulation Scientist - Oral Solid (10-15 yrs)
- Candidate should have exposure on end-to-end product development of oral solid dosage forms i.e. different immediate release, extended-release, delayed release tablets, capsules, pellets, bilayer tablets formulations for US, China and regulated market.
- Having experience on independently handling of end-to-end product development.
- Carrying out extensive literature search and patent infringement analysis for individual product and preparing technical presentation.
- Should have good experience in characterization of API & Innovator's product, reverse engineering of innovator product, selection of excipients, development of punch tooling, selection of packing materials for product.
- Design and execution of pharmaceutical development experiments, pre-formulation trials, development batches, compatibility studies & stability studies as proposed by Group Leader.
- Process optimization and finalization of critical process parameters with QbD concept.
- Compilation, review and verify scientific experiments, analytical data, data documented in electronic laboratory notebooks (eLNB) and technical reports.
- Co-ordination with analytical team and providing product development samples and sample submission planning support as per the project requirement.
- Handling of regulatory queries and familiar with various regulatory guidelines.
- Understanding of scale up factors of different equipment's, familiarize with the problems faced / troubleshooting during scale-up and should have experience of successful technology transfer from lab scale to Plant scale.
- Responsible of execution of pilot bio batch, scale up & exhibit batches/ validation batches as and when required in Cisen India or any other selected manufacturing site.
- Should have knowledge of design and interpretation of bio equivalence study data.
- Preparation of development strategy report, QbD Based PDR, protocols, reports, SOP's, and tech transfer documents i.e., MFR, BOM, sampling protocols, stability protocols etc. of formulation Development dept.
- Ability to work in fast paced, multidisciplinary project teams, and collaborate with colleagues to define and implement screening and characterization strategies according to project timelines.
- Good communication and Coordination skills and ability to work with a diverse cross-functional teams.
Education- PG: Post Graduate in Pharmacy / M Pharm Pharmaceutics, Ph.D in Pharmaceutics