Expert Science & Technology- Oral Solid Dosage

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.