Scientist

1-5 years

Not Disclosed

Hyderabad

15 June 13, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Description Summary

-Design, plan, perform, interpret and report results of scientific experiments for the preparation and timely delivery of drug substances (DS), drug products (DP), processes and procedures within a multifunctional project team coordinated by a Project Leader. Manage technical lab/plant activities. -Management TrackLead a team for the development of pharmaceutical/biological/cell-gene therapies working in a small manufacturing plant environment. Execute the functional strategy and drive operational excellence in line with TRD vision and strategy. Ensure full portfolio support in line with GDD, Sandoz, NTO and NIBR plans. -SANDOZ: -Associate Scientist: Design, plan, perform, interpret and report results of scientific experiments for the development and timely delivery of drug products (DP), processes and procedures within a multifunctional project team coordinated by a Project Leader. Manage technical lab/plant activities. -Scientist: -Design, plan, perform, interpret and report results of scientific experiments for the development and timely delivery drug products (DP), processes and procedures. Lead and manage all project/local network activities, support/coach team members, participate in sub-teams and contribute to overall SZ strategies and goals -Senior Scientist: Design, plan, perform -document and interpret scientific/developmental experiments and GMP testing or pilot plant processes for the preparation and timely delivery of generic products, processes or procedures; maintain and qualify equipment/infrastructure and manage operational aspects in lab or plant as assigned.

Job Description

Major accountabilities:

Independently plan, organize, perform and document scientific experiments /GMP testing /manufacturing plant activities under minimal supervision; handle several activities at a time -Take over responsibility for and utilize special tools /equipment or specialized facilities as an expert; schedule and perform maintenance and qualification of instruments / equipment -Proactively identify conflict situations and contribute to solutions -Work according to appropriate standards for quality, ethics, health, safety, environment protection, and information security; lead initiatives to ensure continuous improvement -Documentation of raw data, evaluate and interpret results; propose and actively support the design of next experiments.
Review and verify raw data generated by others; approval of tests / experiments performed by others -Write protocols, scientific reports or lab procedures based on templates or SOPs under minimal supervision -For technical development units: Develop new methods or optimize existing methods/processes (lab or plant); contribute to development and implementation of new technologies -For GMP units: ensure compliance to cGMP -For technology-focused roles: Perform information and literature searches under minimal guidance.
Actively foster knowledge exchange.
Train and coach associate scientists, technicians, temporary employees and employees under training / education -For project-focused role: Participate in function-specific sub teams and fulfill assigned project tasks and responsibilities under supervision -Uses professional concepts and company's policies and procedures to solve a wide range of difficult problems in imaginative and practical ways.
Contributes to some cost center goals and objectives -SANDOZ : -Senior Scientist : -Design, plan and perform / supervise scientific experiments and contribute to project related scientific /technical activities under minimal supervision (e.g., interpret and report results, generate and evaluate data, draw relevant conclusions, optimize existing methods / processes).
Establish innovative solutions for verification and control of critical quality attributes, critical material attributes or critical process parameter in cooperation with other colleagues.
Establish control procedures and specifications and review test procedures.
Generate scientific documents to hand over to internal and / or external partners (e.g., MST, TechOps, authorities, external companies ) and support generation of international registration documents under minimal supervision.
If assigned this task, maintenance of infrastructure / equipment and required investments ( e.g. system ownership) -Generate lab procedures or SOP’s, generate protocols and reports -Lead technical meetings during product development at the local level as well as on the level of SDC network -Report and present scientific /technical results internally and contribute to publications, presentations and patents.
Report and present scie

Key performance indicators:

Successful execution of assigned tasks within given timelines at expected quality; right first time and right in time -Adherence to appropriate standards as defined in Quality Manual, SOPs, ethical, health, safety, environment (HSE), and information security (ISEC) guidelines -Adherence to costs, quality, quantity, and timelines for all assigned tasks.
Feedback from other team members/leaders.
Refer to annual individual and team objective setting.
Measurable contributions to increasing efficiency and productivity in the work related to assigned projects.
SANDOZ: Senior Scientist:• Successful execution of assigned tasks and work packages• Successful interactions in project teams locally and across development network• Compliance with Novartis / Sandoz rules and guidelines• Positive feedback from leaders, peers, project team colleagues and peers from the networkScientist:Successful execution of assigned tasks and work packages• Successful interactions in project teams locally and across development network• Compliance with Novartis / Sandoz rules and guidelines• Positive feedback from leaders, peers and project team colleaguesAssociate Scientist: -Successful execution of assigned tasks within given timelines at expected quality; right first time and right in time -Adherence to appropriate standards as defined in Quality Manual, SOPs, ethical, health, safety, environment (HSE), and information security (ISEC) guidelines -Adherence to costs, quality, quantity, and timelines for all assigned tasks.
Feedback from other team members/leaders.
Refer to annual individual and team objective setting.
Measurable contributions to increasing efficiency and productivity in the work related to assigned projects.

Minimum Requirements:
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.

Skills Desired

Environment, Experiments Design, Health And Safety (Ehs), Laboratory Instrumentation, Manufacturing Processes, Materials Science, Process Simulation, Project Management, Standard Operating Procedure (SOP), Technical Writing

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