Jobs at CSL

Manage day-to-day office operations in Warsaw including facilities, supplies, travel, fleet, expenses, vendor and contract management, Source-to-Pay (Ariba), SAP/MDG master data, and local Veeva CRM support while driving process improvements and stakeholder communication.

Lead deployment and improvement of the CSL Operating System for Value Stream Bulk. Identify and manage CI projects, run Kaizen/Lean/Six Sigma initiatives, drive KPI governance, digitalization, and performance reporting. Coach leaders, facilitate cross-functional problem solving, ensure compliance in GMP manufacturing, and track benefit realization to improve quality, safety, delivery, efficiency, and operational reliability.

Lead and coordinate project and portfolio activities across R&D, design integrated processes for product development and manufacturing transfer, support technology platforms, monitor project progress and compliance, and contribute to lifecycle planning and risk management under supervision.

Lead and oversee technology transfer and outsourcing for processes and QC analytical methods between development, manufacturing, and external partners. Define transfer strategies, protocols, acceptance criteria, and readiness assessments; serve as technical lead with CDMOs and contract labs; provide scientific oversight, resolve deviations, support CMC regulatory documentation and health‑authority interactions, and drive post‑approval lifecycle changes. Manage large projects, mentor staff, and collaborate cross‑functionally to ensure product quality and continuous improvement.

Perform infectious serology, NAT testing, clinical chemistry, immunohematology and hematology. Lead and train laboratory staff, maintain GMP-compliant documentation, support lab manager with materials, scheduling and process optimization, and assist in daily operational tasks including ordering and external service coordination.

Lead all financial operations for Romania: budgeting, forecasting, FP&A, reporting, tax, treasury, compliance and audits. Provide strategic financial guidance to affiliate leadership, drive performance metrics, enable operational excellence, partner cross-functionally, and mentor finance staff.

Lead design and implementation of enterprise programming standards and reusable SAS macro frameworks. Own and modernize shared SAS macro libraries and automation tools, ensure CDISC-compliant workflows, support Statistical Computing Environment operations, drive governance, train teams, and collaborate across data management, statistics, clinical and quality functions.

Lead CMC strategy and execution for pharmaceutical/biologic programs across development and early commercialization. Support process and analytical development, manufacturing tech transfer with CDMOs, GMP compliance, and author CMC regulatory submissions. Manage risks, partner relationships, and cross-functional stakeholders to meet quality, regulatory, and business objectives.

Lead and support R&D laboratory work to discover and develop medicines; conduct analyses, manage research information systems and technical documentation; design experimental and manufacturing-transfer processes; contribute to portfolio prioritization, resource allocation, risk management, and project reporting; collaborate with internal and external partners, adhere to regulatory and safety requirements, and perform routine lab tasks under supervision while resolving operational issues.

Lead biostatistical strategy for preclinical and translational research, design experiments, perform analyses, support regulatory filings and publications, collaborate with cross‑functional teams (bioinformatics, PK/PD, imaging), and build external partnerships to enable clinical development.

Lead and develop a team to govern and validate clinical data builds, vendor deliverables, and data integrations. Implement and maintain CDASH/SDTM/ADaM standards, validation libraries, and submission-ready processes. Oversee data ingestion into the Clinical Data Warehouse, drive automation (SAS, Python, AI), maintain SOPs/QMS, and partner with Biostatistics, Data Management, Standards, and CROs to ensure high-quality, analysis-ready datasets.

Provide comprehensive administrative support to senior R&D leaders: manage complex calendars, prepare meetings and materials, coordinate domestic/international travel, process expense reports and corporate card reconciliations, plan events and projects, monitor budgets, support onboarding, maintain confidentiality, and liaise with internal and external stakeholders.

Design and govern R&D data architecture connecting discovery, clinical development, regulatory and operations. Own enterprise data models, integrations, automation and AI data designs; produce architecture roadmaps, end-to-end data flows, and mentor teams while ensuring scalability, security and regulatory compliance.

Conduct and support analytical testing and R&D activities under supervision, apply foundational scientific knowledge, coordinate local and global projects, document results, contribute to process optimization and cross-functional teamwork, and follow laboratory safety and procedures.

Execute laboratory and process development experiments, generate and analyze reproducible data to support process characterization and QbD activities, prepare compliant lab documentation and technical reports, contribute to life‑cycle management and process improvement, and collaborate cross‑functionally while adhering to safety, quality, and regulatory requirements.

Lead operational delivery of global, cross-functional R&D projects. Manage budgets, timelines, scope, risks, and reporting; ensure documentation in PM systems; coach junior PMs; coordinate senior management updates and drive tactical execution to meet business objectives.

Lead establishment and maintenance of Portfolio Development processes, SOPs, training, and change initiatives. Drive process improvement, cross-functional programs, and procedural compliance to support clinical trial planning, evaluation, and reporting across global teams.

Lead global human factors strategy for medical devices and combination products. Embed HF in design controls, run formative and summative usability studies, perform risk assessments per ISO 14971, support regulatory submissions (FDA, EU MDR), collaborate cross-functionally, and mentor junior staff to ensure safe, effective, and user-friendly products.

Manage end-to-end R&D contract administration and business operations, including drafting templates, executing contracts, vendor setup, PO creation, invoice resolution, recordkeeping, audits, stakeholder liaison with Procurement and Compliance, and supporting operational tracking and reporting.

Designs and implements AI, automation, and analytics solutions for supply chain. Develops data models, governance, reporting, and advanced analytics; collaborates with process owners to enable data-driven decisions and trains/supports business users.