Senior Manager
CurrentRole & Responsibilities at Semler Research Center Pvt. Ltd.:• Leading a team of analysts. •Preparation of commercial estimates for the development of projects based on the requirement of customers•Participate in the initial meetings with customer on project discussions•To participate in the regular teleconferences and update required information to the customers as per milestones.•Preparation of work plans, analytical strategy plans, timeline estimations and project proposals.•Preparation of Scope of work for new projects based on requirement of customer•Literature survey. Study of the documents related to project provided by the customer like RFQs (Request for Quotation). Study of open part of DMF documents, FDA review documents like Summary based approval of Clinical Pharmacology and Biopharmacetics review and other NDA/ANDA documents provided by CDER.•Identification of required resources, techno-commercial evaluation and short listing of equipment manufacturers/suppliers.•Identification and review of DMF source global suppliers for API, excipients and primary packing components.•Review of protocols for study related for example: preformulation, stability studies analytical method validation, analytical method transfer…. •Monitoring and review of Stability studies sampling, analysis and report generation on the scheduled points.•Review of intermediate and final product development report to be submitted to customers.•Communications to customers for the project requirements.•Preparation, review and approval of quality system SOPs and equipments SOPs for all the available equipments in the department.•Technology transfer discussion and activities at customers place.•Documentation support for the sponsor for dossier compilation.•Handling regulatory affairs.
