Job Description

Summary Plan and perform scientific experiments (or pilot plant processes) 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. Plan and perform scientific experiments (or pilot plant processes) for the development and timely delivery of 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 experiments in agreement with quality risk management and GDevP /GMP -Assists in the preparation of and reviews of the technological part of dossier

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 Project Leader, 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. (eg. contribute to interpretation and report results) -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 analytical methods and develop more efficient ones.
• Generate lab procedures, reports and /or instructions and/or SOP's
• Adherence to 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 instruments /equipment including responsibility for selected equipment.

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:

• M.Sc. /M. Pharm/ Ph.D. with relevant experience.
• Good knowledge of English and site language (oral and written). Recognized expertise in a GxP area 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

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