Analytical Subject Matter Expert (SME)

Job content

Make your mark for patientsWe are looking for an Analytical Subject Matter Expert (SME) who is curious, proactive and problem solving to join us in our Analytical Sciences Pharmaceuticals Department, based in Braine-l’Alleud, BelgiumAbout The RoleThe Analytical Subject Matter Expert in Drug Substance (DS), Drug Product (DP) or Analytical is accountable for:

• Delivering assigned project work packages/transversal activities.
• Participating in project sub-team (DS, DP or analytical) as SME representing own area of expertise providing input to support the elaboration of project strategy.
• Coordinating and managing activities internally and/or externally to deliver assigned work packages and to design, plan, perform, interpret and report results of experiments in time to influence project decisions and next steps.

Who You’ll Work With

• Michel Wagneur as your Manager as well as many talented peers and other internal and external partners.

What You’ll Do

• Participate and contribute in DS, DP or Analytical project sub-team to support the elaboration of project DS, DP or analytical strategies by sharing information, plans and results and taking responsibility for designated tasks associated with own area of expertise.
• Coordinate, manage and execute technical activities internally and/or externally for 1 or 2 assigned work packages to required quality, quantity, time and budget DS/DP batch production, DS & DP process optimization, analytical method development & validation, stability program, route evaluation, form selection, material characterization…
• Design experiments/trials and studies in accordance with Operating Model to support projects DS, DP or Analytical Development with little to no supervision.
• Analyze and interpret own data to influence decisions and next steps . Collaborate & support laboratory technicians and scientists to deliver activities related to assigned work packages.
• Author quality protocols and reports according to data integrity requirements to support regulatory filings.
• Contribute to the transfer of know how to other departments or external contractors, including troubleshooting and on-site training.
• Apply operating model to ensure the right things are done at right time relying on the strategy/guideline documents that will be embedded in the operating model.
• Openly collaborate with other SME’s to ensure technical activities requiring support from other teams or functions can be supported transversally and delivered to plans.
• Support DS, DP or Analytical Project Lead by providing resource and timelines for specific activities .
• Openly communicate new risks, deviation from forecasted plans to DS, DP or Analytical Project Leadand sub-team
• Provide support related to area of expertise in audits and health authority’s inspection as required.
• Collaborate and support/mentor laboratory scientists in execution of experimental work .
• Contribute to departmental goals and priorities in a collaborative manner.
• Contribute to departmental technical and scientific objectives as it relates to own area of expertise.
• Contribute to Pharma Sciences innovation, Science & Technology projects as it relates to own area of expertise.
• Maintain up-to-date knowledge of own area of expertise and participate in academic collaborations, scientific conferences and as a contributor to scientific publications, presentations and patents.
• Communicate, address and solve problems within own area of expertise as they arise, identifying and implementing innovative solutions to resolve them.

Interested? For this role we’re looking for the following education, experience andskills

• Master’s degree with at least 2 years of relevant experience or bachelor’s degree with at least 4 years of experience within the pharmaceutical industry.
• Technical expertise in a specific area of DS, DP or Analytical Development.
• Knowledge of GMP and regulatory requirements.
• Some Project & Risk Management skills required.
• Very good command in both English and French.

Are you ready to ‘go beyond’ to create value and make your mark for patients? If this sounds like you, then we would love to hear from you!About UsUCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 8,500 people in all four corners of the globe, inspired by patients and driven by science.Why work for us?At UCB, we don’t just complete tasks, we create value. We aren’t afraid to push forward, collaborate, and innovate to make our mark for patients. We have a caring, supportive culture where everyone feels included, respected and has equitable opportunities to do their best work. We ‘go beyond’ to create value for our patients, and always with a human focus, whether that’s on our patients, our employees or our planet. Working for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential.Learn more about sustainability at UCB and how it is integrated into our business approach.UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. We do not discriminate on the basis of race/colour/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.