Associate Expert Science & Technology

Job Description Summary

Plan and perform scientific lab experiments for the preparation and timely delivery of drug substances (DS), drug products (DP), processes and procedures in collaboration within a multifunctional project team coordinated by a Project leader. Contribute to maintenance of lab instruments/infrastructure. Support development projects aiming the development of stable, bioequivalent, robust and cost competitive dosage forms. Design and manage experiments/batches for simple/low complexity products under supervision, provide related scientific documentation. Plan and execute analytical experiments and assist in the preparation of reports.

 

Job Description

Major accountabilities:

• Meet quality, quantity and timelines in all assigned projects.
• Plan, organize, perform and document scientific experiments /plant activities in collaboration with experienced team members if necessary.
• Seeks proactively for support and coaching from Scientific Expert or other team members during the whole process if necessary.
• Plan and perform scientific experiment /plant activities and plan, perform and contribute to project related scientific/technical activities under minimal guidance from more experienced team members under guidance. ( e.g. contribute to interpretation and report results) -Provide efficient and robust processes for the manufacture and /or specialized facilities with adequate guidance.
• Provide efficient and robust processes for the manufacture and /or specialized facilities with adequate guidance.
• Provide raw data documentation, evaluation and results interpretation.
• Propose and provide input for the design of next experiments.
• Optimize existing methods (lab or plant) and develop more efficient ones.
• Generate lab procedures, reports and /or instructions and/or SOP’s.
• Actively transfer procedures /instructions to pilot plant or production, including troubleshooting, process steering controls etc.
• Actively transfer procedures /instructions to pilot plant or production, including troubleshooting, process steering controls etc.
• Uses professional concepts and company's policies and procedures to solve a variety of problems.
• Receives detailed instructions on all work - Plan, organize, perform and document scientific experiments/plant activities under supervision.
• Provide raw data documentation, evaluation and results interpretation.
• Propose and provide input for the design of next experiments.
• Adherence to Novartis standards, in particular quality (cGxP, data control), ethical, health, safety, environment (HSE), and information security (ISEC).
• Review and verify raw data generated by others.
• Perform the transfer of procedures to other departments or qualification/validation of procedures under supervision-Optimize or troubleshoot existing methods/processes and develop new methods /processes based on published methods/processes under supervision
• Address and solve problems of high complexity under minimal supervision.
• Provide solutions on deviations and unexpected results from experiments.
• Participate in function-specific teams and fulfil assigned project tasks and responsibilities under supervision.
• Actively maintain laboratory inventory (e.g. chemicals, raw materials, consumables) within own area of responsibility.
• Collaborate within and with other groups and sites.
• Schedule and perform maintenance and qualification of analytical instruments /equipment including responsibility for selected equipment.
• Contact supervisor / vendor in case of unresolvable problems.
• Generate lab procedure
• Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt

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 quality, quantity and timelines for all assigned tasks.
• Ensures reproducibility of experiments and results.

Minimum Requirements:
Work Experience:

• MSc/M Pharm with 2-3-year Industry experience

Skills:

• Basic knowledge 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.

 

Skills Desired

Environment, Health And Safety (Ehs), Laboratory Equipment, Manufacturing Process, Materials Science, Process Simulation, Sop (Standard Operating Procedure)

Global pharmaceutical company focused on innovative medicines in oncology, immunology, and neuroscience. Headquartered in Basel, Switzerland.

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