Gandhinagar

Looking for clinical Database Developer experience in eCRF build and edit checks build in Veeva studio; Create eCRF specifications, design, develop and unit test and functionally validate clinical trial setup process. Providing support for the mapping and transformation of clinical data to CDISC SDTM standards. Work independently and accountable for study Data Management deliverables; Coordinate with Biostatistician, Clinical, Medical and local study team as applicable

M.Pharm / M.Sc; HPLC/GC/IC method development, feasibility, verification, equivalency, validation for API, complex OSD products, oncology products, topical products having exposure to regulated, Semi Regulated and India markets; Good understanding and hands on experience of analytical instruments like HPLC, IC, GC etc.

M.Sc. / M.Pharm, Technically competent on analytical method development and Validation of complex products like liposomes, transdermal, long acting injectable, suspensions, Nano particles, Microspheres, topicals and peptides. Responsible for developing, establishing, and validating analytical testing methodologies, transfer; ensure all analytical testing activities are in compliance with applicable regulatory guidance. 

Formulation development of Injectable including development, execution, filing and approval of Complex Injectables viz. Liposomes, Peptides, long acting emulsions, suspensions, in-situ gels, Lyophilised injectable etc.

A masters degree on a point scale wherever the grading system is followed with Ph.D. in a concerned, relevant, allied subject from an Indian University or an equivalent degree from an accredited Foreign University. 

Conduct high-quality research in molecular biology and industrial biotechnology. Design and execute experiments, analyze data, and interpret results. Collaborate with a multidisciplinary team of scientists and researchers.

HPLC, GC method development for OSD & API having exposure to regulated, Semi Regulated and India markets including Complex generic, F2F, Topical and Dermaceuticals, Peptides, Oncology.

Ph.D. in Biotechnology, Bioinformatics, Biochemistry, Life science or equivalent degree OR 2. Having 3 years of experience in research design and development after M.V.Sc, M.Tech in Biotechnology, Biological Sciences, Bioinformatics, Life Sciences, Molecular Biology with at least one research paper published in Science Citation Indexed

Ensure the on-time filing of high-quality regulatory submission, and to assist in the preparation, maintenance, and control of regulatory dossiers. Interact with Regulatory agency on regulatory submissions and follow up for drug product approvals.