Analytical Scientist

• You will be primarily responsible for implementing, developing, and leveraging the analytical technologies, platforms, processes, and knowledge management required to efficiently solve existing and future analytical development challenges.
• You will implement/develop/maintain technological analytical platform(s) based on spectroscopy/spectrometry/physical measurement of Drug Substances (DS) and Drug Products (DP)
• You will support the mass spectrometry activities by developing and improving the characterization, quantification and structural identification of compounds in DS and DP.
• You will support the development of the API and DP processes by providing relevant platform, technology, analysis and reporting.
• You will be responsible for coaching the analysts/scientists involved on specific analytical platforms /technologies /processes.
• You will be actively involved in method and technology transfer and regulatory submissions preparing with internal and external business partners.
• You will actively participate to the development roadmap and guidance, technical implementation, scientific and operational workflow definition, automation of the process/technology you will be responsible for.
• You will implement digital solutions (equipment, process and data) that deliver value in terms of efficiency and compliance.
• You will be responsible for the compliance with relevant regulations (GMP, HSE, ISO140001..) and SOPs

• You have knowledge in pharmaceutical DS and DP analytical development and technologies for NCE.
• You have proficiency with QbD development and data processing/management tools.
• You have a detailed understanding of regulatory and GMP quality constraints.
• You have in-depth knowledge in key analytical techniques including liquid and gas chromatography mass spectrometry with multiple ionization modes, … (working on Thermo Scientific instruments (Orbitrap) and knowledge of Chromeleon is a plus).
• You have demonstrated capacity to work in a matrix organization in different technical areas.
• You have demonstrated capacity for developing and managing projects with outsourced resources.
• You have demonstrated good interpersonal, verbal, and written communication skills with ability to balance multiple priorities.
• You have key technical backgrounds (depending on scientist key accountability(ies): EU, US and JP regulations, small-molecule chromatography (HPLC/GC) and detection techniques (UV/Vis). You'll need to demonstrate the ability to work effectively in a matrix organization and manage projects with outsourced resources. MS); PAT and chemometrics; NMR and MS spectrometry; dissolution techniques, USP, EP, and JP pharmacopeias.
• You are able to find technical solutions and activate all appropriate internal /external experts to solve the issue.
• You are able to efficiently translate acquired data into knowledge answering the project needs.
• You are able to independently manage scientific tasks in order to meet deadlines within given constraints in resources, e.g. headcount, equipment, time, etc.

UCB