Formulation development in solid orals tablets, Capsules, Pellets, Soft gels. Should have experience in extended release, delayed release, multiparticulate.
Manufacturing, filtration, filling, Lyophilization, sealing, and pre- and post-manufacturing activities. Planning and execution of batch manufacturing activities, filling activities, lyophilization, sealing activities, and filter integrity. Monitoring NVPC and trending.
MSc or PhD in Life Science with specialization and or work experience in Molecular Parasitology, Genome Engineering, Cell Biology, Biochemistry and Bioinformatics
direct recruitment of Faculty on a regular basis through open competition; Ph. D. with first class or equivalent grade at the preceding degree in the appropriate branch, a very good academic record throughout, and Teaching/ Research/ Industrial experience with published work of high quality. Well- recognized and established reputation for having made a conspicuous seminal contribution to knowledge in pharmaceutical and allied areas.
interface with the Amgen Global, Site, Biosimilars, and/or Device RA CMC teams for specific strategies or activities that impact a product. Lead submission for annual reports, facility registrations, facility renewals, and product renewals. Interact with authors, reviewers and subject matter experts with respect to delivery of CMC documents required for regulatory submissions.
Responsible for timely preparation of collaborative testing protocols for new/replacement RS lots, technical assistance for collaborating labs. To review the analytical data received from the Collaborators and to prepare summary reports and RSCEP packages, preparation of packaging and QC testing instructions and assigning periodic re-test intervals.
M.Sc, M.Pharm, M.V.Sc from recognized University, Institute. 2 years of experience of research, teaching in Central State Govt. Organizations, University or Research Institution or Central, State autonomous or other recognized Institute of repute.
Elucidating the role of Cdk-related kinases Crk7, Crk9, and Crk11 mediating transcript maturation in the asexual developmental stages of Toxoplasma gondii. Master degree in Life Sciences from a recognised university or equivalent. Candidates with prior experience in molecular parasitology and molecular biology techniques involving gene cloning and protein purification will be preferred.
Candidate should have experience with the GEA Granulation line, compression processes in the oncology sector, and coating with Glatt and ACG equipment. Experience in handling regulatory audits is a must. Proficiency in English communication is required.