Senior SME Drug Product Expert - Synergy > Joboolo BE :
Company : SRG Location : From : Talent BE
Responsibilities:
Seniorexpert in clinical DP development accountable for leading and running assigned project work packages, ranging from clinical formulation orientation work for FIH study up to commercial registration and launch for the development pipeline and as part of the life cycle management of commercial brands.Contribute to project sub-team as senior SME representing own area of expertise and actively contributing to the elaboration of project strategy.To identify scientifically the best formulation and process for accelerated, standard and enabling clinical formulations by designing, planning, performing, interpreting and reporting results of experiments in time to influence strategic project decisions and recommend next steps.To ensure process robustness, validation and transfer of NCEs and Lifecycle management of product manufacturing process and technologies to commercial launch site.To perform clinical formulation orientation work in collaboration with Non-Clinical Formulation Lead to transition the project from Product Material Orientation (PMO) team to DP dev.
team.
Accountability is on the clinical DP expert side, however close interaction with the NCL formulation lead is expected.Manage CLO/CRO/CMO activities, including selection, negotiation and implementation of appropriate agreements in cooperation with Outsourcing representative.Subject matter expert and trusted partner in DP function working according to appropriate standards for quality (GMP, GSP and GLP), ethics, health, safety, environment, protection and IT; leading functional initiatives to ensure continuous improvement.
Contribute to DP project sub-team to the elaborate project DP strategies by proactively sharing plans, information, data and conclusions and taking full responsibility for all designated tasks associated with own area of expertise.Autonomously coordinate and manage technical activities for assigned work packages internally and/or externally to required quality, timeline and budget eg.
DP clinical campaigns, DP process optimization, stability program, route evaluation, form selection, material characterization.Design experiments/trials and studies in accordance with Operating Model to support projects DP development in an autonomous manner.Evaluate and interpret data with different degree of complexity, draw relevant conclusions; openly collaborate with laboratory technicians and scientists to deliver activities for assigned work package; perform complex tasks without having established procedures.Work according to appropriate standards following the principles of Quality by Design (QbD).Requirements:
Use scientific expertise to design technical experiments independently/autonomously in order to resolve complex problems.Proven ability to critically interpret results, build new experimental hypotheses, and take calculated risks and smart decisions.
Coaches and encourages team members to adopt risk-based approach to own activities.Problem solving mindset.
Ability to propose solutions and/or seek for inputs/advices within the team, department and beyond Pharma Science.Demonstrated ability to collaborate effectively across teams within and beyond own department.Proactive, self - motivated and independent working style and able to manage own activities independently/autonomously to drive smart decisions.Excellent ability to build collaborative relationships and a can-do mind-set.A mind-set of curiosity, creativity, collaboration and openness to diverse thinking, with an enthusiasm to develop self and others. SRG
