Expert- Science and Technology

14 hours ago


Telangana, India Novartis Full time

**Summary**:
Design, plan, perform, interpret and report results of scientific experiments for the method development of drug substances (DS) and drug products (DP) within global ARD. Lead and manage all project/local network activities, support/coach team members, participate in sub-teams and contribute to overall TRD strategies and goals.

**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.

Division

Development

Business Unit

Innovative Medicines

Location

India

Site

Telangana

Company / Legal Entity

IN10 (FCRS = IN010) Novartis Healthcare Private Limited

Functional Area

Research & Development

Job Type

Full time

Employment Type

Regular

Shift Work

No

**Accessibility and accommodation**:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.



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