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Sona***********
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India
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Last Update: 15.05.2019 at 11:16
Job Type
Permanent
Start
May , 2019
Duration
6 Month
Place
Hyderabad, IN
Country
India
Category
Research Positions
Description
Major Accountabilities Product Development and Transfers Support the development and transfer of oral drug products by evaluation of material, formulation and process parameters by means of applied statistics Lead capture and aggregation of scientific data with the aim to create and maintain database of raw data Utilize DoE concepts and QbD principles to achieve robust formulations and processes Cooperate with the statistical experts of TechOps to enable a smooth process handover Work extensively with formulators both 1 1 and in meetings to work with the DoE’s & data models in terms of design, and in interpreting the results Work extensively on desiging mechanistical models of technological processess and IVIVC work hand-in hand with our formulation experts and engineers to enable the successful process transfers to production support the achievement of robust formulations and processes as well as the introduction of quality by designs (QbD) principles Contribute to risk assessments, e.g. FMEA or risk matrix. Planning and evaluation of Design of Experiments (DoEs) in the frame of the Novartis Quality by Design validation strategy. Act as an interface to the formulation team and the IVIVC team (analytical) to assist in the IVIVC modeling, data interpretation, BE assessment etc as per need. Process validation and transfer, in particular Process Analytical Technology (PAT) methods Support the design of an analytical robustness test, e.g. by means of DoE. Work with analytical team to develop DoE’s for optimization of analytical methods Work together with PAT-experts from drug substance and drug product process development to support in DoE, chemometrics and data integrity checks Statistical assessment of method validation data Training & data evaluation Enable the Site to have the necessary competencies in applied statistical & data handling tools by designing and delivering training on available tools and how to use them in practice, providing ongoing coaching. Provide training in DoE and basic statistical concepts to clients in forms of short courses and/or seminars Instruct how to collect (e.g. sampling plans which are statistically meaningful), set up and interpret data sets and statistical results highlighting constraints and limitations. Support on data mining, trending and other data related activities to get meaningful results. Key Performance Indicator Successful execution of assigned tasks and work packages Successful interactions in project teams Compliance with Novartis / Sandoz rules and guidelines feedback from leaders / peers Minimum Requirements Advance degree in statistics/pharmacy / physics/chemistry/engineering or equivalent experience. Fluent in English and proficient in site local language. Proven experience of at least 6 years of applied statistics in the pharmaceutical environment. Experience in design of experiments (DoE) and its analysis is crucial. Familiarity with the statistical aspects of formulation experience in using SAS, JMP or Minitab Experience in data aggregation Experience in data mining, SIMCA and Monte Carlo simulations are a plus Experience in the field of drug product development of PAT-tools are a plus. Proven experience of applied statistics is a must, e.g. in the field of DoEs and multivariate data analysis. Experience in the following software is a plus SAS, R, Minitab, SIMCA-P+, Modde, JMP, SPSS. Division SANDOZ Business Unit Product Dev SZ Country India Work Location Hyderabad, AP Company/Legal Entity Nov Hltcr Shared Services Ind Functional Area Research & Development Job Type Full Time Employment Type Regular