Expert Science

4 days ago

Hyderabad Telangana, India Novartis Full time

**Summary**:
Perform and document scientific experiments in the laboratory for drug substances (DS) and drug products (DP) in collaboration with multifunctional project teams. Contribute to maintenance of lab instruments/day-to-day operations. Timely execution of project related activities to support TRD-NCE strategies and goals.

**About the Role**:
**Major accountabilities**:

- Plan, organize, execute, and document scientific experiments (e.g., analytical
method developments/ validations/ transfers/ stability/ release testing, formulation
development analytics etc.) according to the agreed timelines and appropriate
quality standards.
- Accountable for documentation and submission of raw data in appropriate data
system (for e.g., LIMS test activation and results entry).
- Responsible for good documentation practices (GDP) and good laboratory
practices (GLP) during execution of laboratory activities.
- Support in evaluation and interpretation of results including investigations on SST failures, OOX/Deviations/Change controls as needed.
- Responsible for assigned laboratory related area/activities (e.g.,
chemical/reagents/consumables/samples/column/ glassware management etc.).
- Responsible for implementation and maintenance of lean/efficient/environmentally
sustainable practices in the laboratory.
- Proactively communicate key issues and any other critical topics in a timely manner to the manager and/or to any other relevant project team member(s).
- Responsible to meet KQI (Key quality indicators) and KPI (Key performance
indicators) for all assigned activities.
- Support internal and external audits and ensure no critical findings within the
assigned scope.
- Actively contribute to team and organization goals.
- Work according to appropriate SOPs, GMP, GLP, QM, HSE, ISRM & Novartis
Guidelines.
- Additional specific roles/tasks: See Up4Growth training assignments for the
business roles for the associate as per the team matrix and completion of trainings in transcript of learning system (e.g., Up4Growth).

**Minimum Requirements**:

- Masters in Life Science (e.g., analytical / organic chemistry /pharmacy / pharmaceutical development) or equivalent.
- 5+ years of relevant work experience in OSD forms
- hands on in chromatography, multimedia dissolutions, In-vivo & Invitro dissolutions, quality investigations, QBD etc.
- Fluent in English (oral and written).Knowledge of site language, if required.
- Knowledge in quality principles driving drug development such as GMP.
- Understanding of general regulatory and quality expectations.
- Good scientific background, communication skills including presentation and scientific/technical writing.

**Work Experience**:

- Functional Breadth.
- Operations Management and Execution.
- Collaborating across boundaries.

**Skills**:

- Environment.
- Experiments Design.
- Health And Safety (EHS).
- Laboratory Equipment.
- Manufacturing Process.
- Materials Science.
- Process Simulation.
- Project Management.
- Sop (Standard Operating Procedure).
- Technical Writing.

**Languages**:

- English.

Division

Development

Business Unit

Innovative Medicines

Location

India

Site

Hyderabad (Office)

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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