Job Description Summary
Design, plan, perform, interpret, and report results of scientific experiments for the preparation and timely delivery of drug substances (DS), drug products (DP), processes and procedures within global ARD. Lead and manage all project/local network activities, support/coach team members, participate in sub-teams and contribute to overall TRD.
Job Description
Major accountabilities:
Provide analytical and technical support to PHAD/project team at various stages of product development (eg. 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, dis-tribution, reconciliation/destruction of the samples).
Support planning for assigned project activities. Accountable to meet KQI (Key quality indi-cators) 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 laborato-ries.
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).
Single point of contact for PHAD/project team and other stakeholders (e.g, BioPharm, Mate-rial science and CPP, etc.) for project execution activities.
Support internal and external audits and ensure no critical findings within the assigned pro-jects.
Actively contribute to team goals.
Work according to appropriate SOPs, GMP, GLP, QM, HSE, ISEC & Novartis Guidelines.
Minimum Requirements:
Ph.D in Chemistry/Pharmaceutical sciences with a minimum of 1 years of experience, or M. pharm/M.Sc. with 6 plus years of experience within the pharmaceutical industry, specifically in analytical development.
Work Experience:
HPLC method development
Chiral separation
Languages :
English.
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