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Expert Science & Technology

Expert Science & Technology

NOVARTIS

6 - 9 years

8 - 11 Lacs

hyderabad

Posted:1 day ago| Platform:

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Skills Required

osd method validation glp gmp hse operations hplc chromatography technical support logistics

Work Mode

Work from Office

Job Type

Full Time

Job Description

Design, plan, perform, interpret and report the analytical results of scientific experiments for the preparation and timely delivery of drug substances (DS), drug products (DP), processes and procedures within global ARD. Expertise in analytical method development, method validation as well as technical and strategic background. Manage technical lab/plant activities. Execute the analytical experiments in line with TRD vision. Ensure full portfolio support in line with GDD, NTO and NIBR plans. Maintain and qualify equipment/infrastructure and manage operational aspects in lab or plant as assigned.

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.

Benefits and Rewards

Read our handbook to learn about all the ways we ll help you thrive personally and professionally

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NOVARTIS

Pharmaceutical Manufacturing

Basel Baselstadt

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Expert Science & Technology