Expert Science

Summary The job purpose is to lead and manage all assigned project network activities and apply scientific technical expertise to address complex R D issues for the preparation and timely delivery of drug products DP processes and procedures participate in teams and contribute to overall Technical Research and Development strategies and goals To develop our growing pipeline of products we are looking for experienced professionals in the area of pharmaceutical development In this challenging position you will play a key role in the development of parenteral dosage form The position is based in the Genome Valley Hyderabad within the Technical Research and Development Organization TRD of Global Drug Development GDD Role purpose Design plan perform and interpret scientific experiments to perform chemical and pharmaceutical profiling of NCEs resulting in robust analytical method development solid form characterization and formulation strategy development in collaboration within a multifunctional project team coordinated by a Project leader Manage and contribute to maintenance of lab instruments infrastructure Major accountabilities Ensure the selection of the appropriate NCE during discovery and early phase product development by performing appropriate risk assessments using physicochemical characterization in vitro assessments and in silico assessments Design formulate appropriate pre-clinical PK and tox formulations for parenteral and oral routes Select develop and scaleup appropriate enabling technologies such as nanosuspension amorphous solid dispersions or microemulsion development per risk assessed Design and perform analytical scientific experiments to characterize solubility dissolution pH and permeability for DS and DP Analysis by UV fiber optics UPLC HPLC and other techniques as required SEC IC Raman FT-IR XRPD DSC TGA NMR etc Design plan and perform scientific experiments to support development of new technologies Contribute to project related scientific technical activities either independently or under minimal guidance from more experienced team member Propose and provide input for the design of next experiments Generate and evaluate data Interpret results and document and report result using electronic notebooks eLN according to Novartis electronic documentation processes Author development reports laboratory protocols etc as per need Communicate and address problems perform literature searches Adhere to all health and safety HSE practices appropriate to the site and country Work according to appropriate SOP s and Novartis guidelines Maintain a clean and safe working space Utilize special tools equipment and specialized facilities e g containment facilities for potent compounds Make sure that all deliverables are achieved against agreed project timelines and meeting quality expectations Contribute to selection installation training and maintenance of equipment and infrastructure Manage inventory chemicals excipients consumables and solvents within own area of responsibility Evaluation and implementation of new methods and technologies scientific contributions supervision of research projects and initiation of new research activities Enable Novel Delivery Technologies evaluation as per project needs Proactively support the overall culture of the organization through coaching mentoring providing feedback driving innovation external collaborations and best practice sharing Report and present scientific technical results internally and contribute to peer reviewed publications presentations and patents Fully adhere to all relevant Novartis Policies and Guidelines Role model the Novartis Values and Behaviors Minimum Requirements M Pharm with 7 to 10 years of experience or PhD in Science with focus on pharmaceutical sciences and technology e g Pharmacy Chemistry with 5 years of experience Experience in the development scale-up and technology transfer of Parenteral Drug Product manufacturing processes is required Background in aseptic process development of parenteral product is required Thorough understanding of aseptic fill-finish unit operations i e filling filtration mixing lyophilization etc and equipment for scale-down model development and process characterization is required Experience with regulatory filings IND IMPD etc is required Demonstrated competency and experience in drug product development within the pharmaceutical industry is required Successful work experience in a matrix organization is preferred Good oral written good experience in writing of scientific reports and filing documentation and presentation skills are essential Skills Desired Environment Experiments Design Health And Safety Ehs Laboratory Instrumentation Manufacturing Processes Materials Science Process Simulation Standard Operating Procedure SOP Technical Writing Waterfall Model