Company
pharmaceutical
SeniorExpert,Science&TechnologyAnalyticalExpert
Neural analysis suggests this role is
optimal for Senior candidates.
“Senior Expert, Science & Technology Analytical Expert. Skills: analytical methods development, separation sciences, GMP analytical environment. develop analytical methods to control and monitor the performance of synthetic drug substance manufacturing processes. Supervising GMP activities”
What You'll Achieve.
ensuring the development of highest quality small molecule drug substances throughout the life cycle of each project; support clinical trials; timely delivery of drug substances
Industry & Context.
troubleshooting
What They're Looking For.
Must Have
Masters/PhD in analytical chemistry or equivalent, minimum 8-10 years’ experience in the pharmaceutical industry in analytical development, Recognized achievements in the development of new analytical methods, Successfully demonstrated expertise in a specific scientific/technical area, Proven experience in a GMP analytical environment, coordination and communication skills, collaborative spirit, self-driven attitude, high level of learning agility
Nice to Have
Clinical Data Management, Data Architecture, Data Governance, Data Integration, Data Management, Data Profiling, Data Quality, Data Science, Data Strategy, Master Data, Waterfall Model
What You'll Do.
develop analytical methods to control and monitor the performance of synthetic drug substance manufacturing processes
Supervising GMP activities
define the overall analytical control strategy for the manufacture and timely delivery of drug substances
Providing scientific guidance to external analytical teams
supporting daily business
Supporting CMC document writing and regulatory submissions
managing interactions between internal and external partners
Participation in technical Drug Substances project teams
contribute to overall strategies and goals of chemical development projects
Supporting the setting up of databases and document flow process
Contributing to evaluation
selection and onboarding process of new external partners
Reviewing technical and GPM-relevant documents
How You'll Work.
Team & Collaboration
Working as an Analytical Expert in the External Partner Management (EPM) unit; Guiding external partners; Providing scientific guidance to external analytical teams; Actively managing interactions between internal and external partners; Participation in technical Drug Substances project teams (internal and external); Contributing to evaluation, selection and onboarding process of new external partners
Communication Scope
coordination and communication skills; Contribution to scientific exchange groups within Novartis and externally
Process & Methodology
managing interactions between internal and external partners, Participation in technical Drug Substances project teams
Full Job Description
**Job Description Summary** As part of the Global Drug Development (GDD) team, this role is essential in ensuring the development of highest quality small molecule drug substances throughout the life cycle of each project, required to support clinical trials. **Job Description** **Key Responsibilities** * Working as an Analytical Expert in the External Partner Management (EPM) unit of Chemical and Analytical development (CHAD) in their new group in Hyderabad. * Guiding external partners to develop analytical methods to control and monitor the performance of synthetic drug substance manufacturing processes, with a focus on analytical separation sciences (e.g. HPLC, LC-MS etc.). * Supervising GMP activities such as method validation, specification setting, release testing, deviation handling and change control management * Helping to define the overall analytical control strategy for the manufacture and timely delivery of drug substances * Providing scientific guidance to external analytical teams, supporting daily business, troubleshooting etc. Contribution to scientific exchange groups within Novartis and externally. * Supporting CMC document writing and regulatory submissions. * Actively managing interactions between internal and external partners to ensure a constructive and well-functioning collaboration * Participation in technical Drug Substances project teams (internal and external) and contribute to overall strategies and goals of chemical development projects. Supporting the setting up of databases and document flow process within the EPM unit. * Contributing to evaluation, selection and onboarding process of new external partners. Reviewing technical and GPM-relevant documents **Minimum Requirements** * Masters/PhD in analytical chemistry or equivalent and a minimum 8-10 years’ experience in the pharmaceutical industry in analytical development * Recognized achievements in the development of new analytical methods: main focus on separation sciences, e.g. HP
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