Expert Science and Technology (Nitrosamine/Nitrite)

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.

 

Job Description

Your responsibilities include, but are not limited to:

• Meet quality, quantity and timelines in all assigned projects; Perform and document scientific experiments; Plan & organize scientific experiments under minimal guidance from more experienced team members. Seeks proactively for support and coaching from Project Leader, Scientific Expert or other team members during the whole process if necessary.
• Provide documentation of raw data. Evaluate and Contribute to interpretation and report results under minimal guidance from more experienced team members. Propose and provide input for the design of next experiments. Optimize existing methods (lab or plant) or contribute to new method development and reproduce published methods 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. Communicate and address problems, perform safety and literature searches under moderate guidance from more experienced team member.
• Keep record of and manage chemicals, intermediates, excipients and solvents within own area of responsibility.
• Collaborate with other team members to facilitate deliveries of DS and/or DP. Act as mentors for new joinees.
• Utilize special tools/equipment’s and/or specialized facilities e.g., containment/sterile labs. Evaluate new lab equipment. Schedule and perform routine maintenance and calibration of lab instruments/equipment & contribute to maintenance of infrastructure/equipment.
• Actively participate in project teams/meetings/networks. Actively contributes to team goals.
• Ensure all own activities are aligned with overall drug development process.  Work according to appropriate SOPs, GMP, GLP, QM, HSE, ISEC & Novartis Guidelines ;Strategic and scientific contribution to Networks, target achievements according to net-work charter and annual objectives

WHAT YOU’LL BRING TO THE ROLE:

• PhD on technical subject with relevant experience. or Master of Science with 4+ years of relevant experience Fluency in English language.
• Awareness for safe handling of chemicals, potentially dangerous materials and equipment. Broad theoretical and scientific knowledge in the relevant area (e.g. manufacturing, analytical, pharmaceutical).
• Skilled scientist with expertise in trace level quantification of GTI/ Nitrosamines/Nitrites or similar impurities using LC-UV/FID, Ion chromatography and LCMS.
• Experience on dealing OOS/OOE and deviations involving above mentioned analytical techniques.
• Proficient with laboratory and/or technical tools. Good knowledge of software and computer tools.
• Good documentation skills.

 

Skills Desired

Environment, Experiments Design, Health And Safety (Ehs), Laboratory Equipment, Manufacturing Process, Materials Science, Process Simulation, Sop (Standard Operating Procedure), Technical Writing, Waterfall Model