Summary
About the Role
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.
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Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
