Analytical Chemistry Scientist - Porto, Portugal - Bial

Bial

Empresa verificada

Porto, Portugal

há 1 semana

Postado por:

João Santos

Recrutador de beBee

Descrição

MISSION:

The selected R&D Analytical Chemistry Scientist will be part of the Analytical Sciences Team within the Drug Enabling Sciences Department - R&D Division.

The team is responsible for all analytical activities related to the development of BIAL's new products (drug substance and drug product), from Research through to Commercial phase, with depth understanding of the compound properties and Target Product Profile.

MAIN ATTRIBUTIONS AND RESPONSABILITIES:

Design and execute phaseappropriate analytical method development, validation and transfer for new drug substances and new drug products (small molecules).
Ensure appropriate analytical control strategy and specification setting, according to project ́s stage.
Guarantee technical interaction with external partners, to facilitate and review analytical activities, as well as to ensure the completion of agreed activities, within the required timelines.
Prepare analyticalrelated CMC sections of IND/IMPD and MAA regulatory submissions, ensuring that analytical deliverables are met and aligned with technical content.
Contribute towards product development from Research to Commercialization by collaborating with multiple functions within the R&D Division, to improve analytical, process and product knowledge.
Collaborate with peers within the Drug Enabling Sciences Department, to promote strategic alignment and successful achievement of shared goals.
Ensure clear communication of analytical results and project status, to managers and/or nontechnical audience.
Ensure an active understanding of the new trends of analytical development and validation, to build adaptable approaches for the future.
Collaborate with internal and external partners, to strategically drive innovation and promote scientific excellence.
Plan and organize daily priorities within the assigned tasks, to accurately meet the requirements and timelines of each project.

REQUIREMENTS & SKILLS:

Master or PhD in Pharmaceutical Sciences, Chemistry or related analytical sciences (PhD preferred).
5 years of previous industry experience (minimum required), including significant knowledge in analytical sciences, cGMP compliance and CMC regulatory requirements in R&D specifically within the analytical sciences field.
Proven knowledge and experience with phaseappropriate analytical method development, validation and transfer of new drug substances and new drug products (small molecules preferred).
Proven knowledge and experience in analytical techniques, namely, Chromatography, Laser diffraction, Karl-Fisher titration, XRPD and other small molecule characterization techniques.
Strong knowledge of Dissolution test, Dissolution profile similarity test and in vitro equivalence assessment.
Experience with laboratory systems and statistical techniques for analytical methods.
Strong knowledge of ICH and other relevant regulatory guidelines, as well as, EU and USA CMC regulatory requirements, in all stages of analytical development, to ensure highquality standards of regulatory documentation preparation.
Creative profile, with initiative competencies and innovation in problem solving (is valued).
Strong organizational skills and attention to detail for establishing priorities and meeting timelines.
Focussed on promoting a healthy and inclusive working environment.
Ability to effectively adapt to new organization structures and dynamics within a fastpacing environment.
Passionate about analytical sciences within a R&D environment.
Fluency in English (written and spoken).