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