摘要
About the Role
Major accountabilities:
- 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).
- Single point of contact for PHAD/project team and other stakeholders for project execution activities.
- Support internal and external audits and ensure no critical findings within the assigned projects.
- Actively contribute to team goals.
- 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.
Minimum Requirements:
Work Experience:
- MSc/M Pharm with 6–9 year Industry experience
- Ph.D. with 2–3-year Industry experience
Skills:
· Proficiency in developing and validating analytical methods for Assays, Impurities, Dissolution, Content uniformity for OSD and parental formulations.
· Familiarity with ICH guidelines and regulatory expectations for method validation, Analytical Target Profile (ATP) and lifecycle management of analytical procedures, Good Laboratory Practices (GLP) and ALCOA+ principles.
· Hands-on experience with HPLC and UPLC (with Empower and chromeleon), UV-Vis, DVS, Dissolution testing systems.
· Apply best practices in LC chromatography and sample preparation for reproducibility and accuracy.
· Ability to troubleshoot and maintain analytical instruments
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.
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
