Drug Product Expert
il y a 1 semaine
Make your mark for patients
We are looking for a
Drug Product Expert to join us in our
Product Development team, based in
Braine-l'Alleud,
Belgium
About the role
- Lead and run assigned project work packages/transversal activities.
- Contribute to project Drug Product (DP)subteam as SME representing own area of expertise and actively contributing to the elaboration of project strategy.
- Work autonomously to coordinate and manage activities internally and/or externally to deliver work packages with different level of complexity and to design, plan, perform, interpret and report results of experiments in time to influence strategic project decisions and recommend next steps.
- Contribute to setting and delivering departmental goals & priorities.
- Supportthe advancement of Pharma Science's Science & Technology and Innovation projects by leveraging own area of expertise to lead functional initiatives and contribute to Pharma Sciences (PS) transversal initiatives.
Who you'll work with:
-
Flore Depreter as your Manager and many other colleagues active in transversal responsibilities.
What you'll do:
- Subject matter expert (SME) and trusted partner 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 subteam 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
- 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.
- Autonomously write high quality source documents including experiment plans, protocols and reports according to data integrity requirements to enable regulatory filing. Support department with the review of protocols and reports from other SME's.
- Lead the transfer of know how to other departments or external contractors, including troubleshooting and onsite training.
- Closely collaborate with other SME's within PS, UCB community across functions and organizations to ensure delivery of crossfunctional technical activities to quality time and to develop patient centric solutions.
- Support DP PL by providing resource and timelines for specific activities.
- Use technical and regulatory knowledges to anticipate Health Authorities expectations and identify risks.
- Proactively communicate risks and deviations from forecasted plans.
- Take an active role for area of expertise in audits and interactions with Health Authorities and inspection as required.
- Collaborate, support and provide scientific mentoring/coaching for laboratory scientists and less experienced SMEs in execution of experimental work.
- Contribute to departmental goals & priorities in a collaborative manner
- Contributes to setting the sciences and technology strategy direction of the department as it relates to own area of expertise.
- Maintain an uptodate knowledge of own area of expertise to be recognized as a technical expert within own function and across PS.
- As an expert contribute to scientific publications, present at conferences and represent area of expertise on industry boards and through academic collaborations.
Interested? For this role we're looking for the following
education, experience
and
skills
- Master's degree preferred in a related field.
- At least 5 years of proven experience in Pharmaceutical Development and/or Manufacturing.
- Proven and recognized technical expertise in a specific area of Drug Product Development.
- Experience in GMP and regulatory requirements.
- Experience in authoring source documents and/or regulatory modules.
- Project Management abilities needed to coordinate/manage activities internally/externally and to forecast resources and timelines.
- Very good command in English.
Soft skills:
-
Excellent communication and presentation skills: to convey information in a clear and concise manner to write clear instructions, protocol and reports.
-
Problem solving: to propose solutions and/or seek for inputs/advices within the team, department and beyond Pharma Science or UCB.
-
Proactivity: to manage own activities independently/autonomously to drive smart decisions.
-
Curiosity: to diverse thinking, with an enthusiasm to develop self and others.
Are you ready to 'go beyond'
-
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