摘要
About the Role
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:
- Recognized expertise in analytical methodology and broad scientific as well as technical and strategic background.
- Demonstrated successful experience with working in interdisciplinary and cross-cultural teams.
- Demonstrated leadership and advanced coaching and mentoring skills.
- Thorough knowledge of relevant SOP, GMP and Novartis regulations and policies if applicable.
- Excellent communication/presentation skills and scientific.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
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Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
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.
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
