Job Description

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