Archieven: Job Listings

• Location: Braine-l'Alleud
• Job #27545

Portfolio Manager

Contracting – Brabant Wallon

Your responsibilities:
As a TST Portfolio Manager, you will use robust project/portfolio management and communication skills to set-up, structure & coordinate the CMC projects portfolio in line with the Assets & Patient Supply strategic plans for (a) given compound(s), managing the inter-connections across projects, ensure coordinated plannings & deliverables, the CMC resource allocation to projects, projects prioritization scenarios, budget, financial 10 years plan & tracking of actuals.
This function implies close relationships within the technical teams, with Global Regulatory Affairs function within the Patient Evidence, Global Quality and Operational functions to ensure alignment with EU, US, JP & IM teams’ expectations.
You are agile, structured, good team player, assertive, enthusiastic and with a positive mindset.
As the TST Portfolio Manager, your main activities and roles & responsibilities will be the below:

• Provide support and coaching to project managers for creating a master plan for their assigned project that includes timelines, required resources, the order of needed tasks, and the responsibilities of each project team member; the record and tracking of this information in the software applications
• Work closely with the project managers to ensure that project milestones are met efficiently and within prescribed budget & resource constraints. Generate monthly reports on schedule adherence.
• Consolidate all relevant CMC projects into a Portfolio per compound, ensuring appropriate links between projects, milestones and resources. Develop dashboard and KPI’s to drive efficiently the product portfolio inside the TST.
• Identify any resource constraints proactively and drive the prioritization-making process in Patient Supply and CMC: prepare (and present) prioritization proposals to the Patient Supply LT or Asset LT for endorsement after TST agreement/discussion.
• Coordinate budgeting effort to align Units, Operations, Functions and Practices to achieve consolidated product projects, budgets and monitoring.
• Drive the increase of maturity on project management skills inside TST’s and identify areas of improvement for the CMC community.
• Coordinate activities and knowledge gathering to ensure issues are addressed and escalated timely across the product portfolio stakeholders, with assertiveness and deep understanding of SME’s constraints on project/portfolio.

Your profile:

• Minimum 5 years of project, program and/or portfolio management experience and in associated tools
• Experience in enterprise planning/resource capability and systems. Knowledge of Planisware PPM tool is a strong asset
• Solid understanding of the end-to-end CMC/Development (and associated disciplines) is a strong asset.
• Languages: English & French
• Robust knowledge of change management
• A certification in PMP, PRINCE2, Agile, Lean or equivalent is a plus
• Knowledge of the pharmaceutical environment; launch and life cycle management processes and the regulations applicable during development is an asset

• Location: Braine-l'Alleud
• Job #27542

Bioanalytical Scientist LC-MS

Contracting – Brabant Wallon

Your responsibilities:
The Precision Medecine (PM) Department is positioned within the function of Translational Science, a division which provides strategy and support to transition novel pharmacological assets, including small-molecule, biologics and gene therapy derived assets, from research into the clinic.
PM operate and collaborate closely across the organization to support bioanalysis and biomarker activities.
About the role:
We are seeking a self‑motivated, lab‑based scientist to support the development of LC‑MS pharmacokinetic assays that will advance our NCE and NBE assets. The lab works in close partnership with the relevant therapeutic area(s). The scientist will also play a pivotal role in transfer of assays into the regulated environment. The individual will also have an opportunity to take on project related responsibilities, executing on tailored bioanalytical strategies.
Who you’ll work with:
Development Bioanalysis is a team that sits within PM and are responsible for multiple key activities, supporting non-regulatory PK, Biodistribution & Immunogenicity assessments for NCE, NBE and Gene Therapy assets whilst also developing bioanalytical methods to support regulatory studies, transferring these methods into the Regulatory team for subsequent validation and testing.
You will operate in a matrix environment, collaborating with a wide range of internal stakeholders including Therapeutic Area project teams, Drug Metabolism and Pharmacokinetics, Non‑Clinical Safety and Quantitative Clinical Pharmacology.
What you’ll do:

• You will support the development and delivery of LC-MS PK assays and associated data sets for our small-molecule (NCE) and biologics (NBE) pipeline.
• Work within the bioanalytical teams to optimize experimental design, sample analysis, data interpretation and report generation.

Your profile:

• Candidates should have at least a BSc in a biological discipline with 1-3 years of hands-on experience in Bioanalysis.
• Experience with a range of analytical techniques supporting small‑ and large‑molecule bioanalysis, including enzymatic digestion approaches and immunocapture purification.
• Biological sample extraction and preparation techniques.
• Experience with cell-based and LBA assays is a plus.
• Proven track record of providing consistent routine high-quality bioanalytical support.
• Assay characterization and acceptance criteria, such as those required for progression of
• compounds into development.
• Continual bioanalytical method development and optimization.
• Trouble shooting of analytical and equipment issues to avoid delays in data generation.
• Good judgement to assess fit-for-purpose bioanalytical assay performance.
• Expert in LC-MS and other analytical tools, ideally Sciex and Waters LC-MS/MS.
• Excellent working knowledge of analytical software packages (Analyst, Sciex OS, Masslynx and Waters Connect).
• Demonstrated knowledge in using ELN (Watson, E-Workbook) and Microsoft Office