Major activities
· Develop and qualify various analytical methods (e.g., fast LC, titration, dissolution).
· Provide analytical and technical support to PHAD/project team at various stages of product development (e.g., CSF, FMI and LCM).
· Design and author analytical documents (e.g., Analytical methods, Stability protocols/reports, Excipient compatibility (EC) protocol/reports; APS protocols/reports, etc.)
· Support Analytical project leader for setting analytical development strategy.
· Support in data interpretation, results compilations and sharing the information with critical observations and proposals to project team.
· Responsible for project related sample handling (e.g., sampling plans, issuance, storage, distribution, reconciliation/destruction of the samples).
· Support planning for assigned project activities. Accountable to meet KQI (Key quality indicators) and KPI (Key performance indicators) for all assigned project activities.
· Provide requests for lab activities to the associates and stakeholders.
· Manage project activities including logistics at third parties and external testing laboratories.
· Proactively communicate key issues and any other critical topics in a timely manner to the appropriate management level and/or to any other relevant project team member(s).
· Work according to appropriate SOPs, GMP, GLP, QM, HSE, ISEC & Novartis Guidelines.
· Subway: Author (EC/APS protocol and reports), review of test methods and compatibility study plan.
· ESOPS: Read SOP access and Review of SOPs.
Ideal background
Education and experience:
M.Sc. /M. Pharm/ Ph.D. with relevant experience.
Languages:
Good knowledge of English and site language (oral and written).
Professional requirement:
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