Ensure overall contract management, including review and approval of external service provider (ESP) contracts, change orders and ensure services are delivered per contract.Act as primary company contact for assigned trial at the country level and ensures local/country team is tracking project progress against planned timelines and monitors patient recruitment rate to ensure that target enrollment will be met across the allocated countries.Drive study compliance by maintaining and updating trial management systems, using study tools and management reports available to analyze trial progress. Participates in preparation for and conduct of Health Authority (HA) inspections and internal Quality Assurance audits.Contribute to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target.Deliver competent vendor management at the country level to support the study and may submit requests for vendor services and support vendor selection.Contribute to patient understanding of protocol and patient safety by contributing to the review of country specific informed consent in accordance with procedural document/templates.Ensure trial subject safety in that all AEs/SAEs/PQCs are reported within the required reporting timelines and documented, as appropriate.Ensure Inspection readiness by maintaining complete, accurate and timely data and essential documents in systems utilized for trial management (e.g.
Proven success in global communications roles, ideally within pharma/biotech or regulated industries; Experience in applied science communications is highly desirable.Proven experience working in a global, highly matrixed environment, collaborating across regions and functions and influencing cross-functional stakeholders.Fluency in German and English, both written and spoken. Reporting Relationship: Role that this position reports to: Director, Communications Business Partner CSL International Roles that report to this position: none What we offer Our benefit plan offers our employees numerous choices including such options as life insurance and retirement plan Up to two additional leave days for your personal wellbeing.
As Process Chemist, you will act as the operational eye of the chemical process, ensuring chemical stability, safety, and product quality throughout solid propellant manufacturing. You will report to the Chemical Manager and work closely with Process Engineering, Production, and Quality teams. Your key responsibilities include: Process monitoring & control - Perform in-process chemical monitoring during mixing, vacuuming, and polymerization stages - Verify critical parameters such as viscosity, temperature, vacuum level, reaction stability, and material homogeneity - Support process adjustments in coordination with Senior Chemical Engineers and Process Engineers - Ensure strict adherence to recipe-specific instructions, SOPs, and defined operational limits Sampling & analytical testing - Collect samples at defined control points throughout the production process - Conduct laboratory analyses, including moisture analysis, viscosity and density measurements, reaction stability assessments, and visual inspections - Ensure correct sample identification, labeling, and full batch traceability Documentation & data integrity - Record all measurements, test results, and observations in laboratory logs and LIMS/ERP systems - Ensure full traceability of batches, deviations, and corrective actions - Support preparation and review of batch records and process documentation Deviation handling & escalation - Immediately report deviations, abnormalities, or safety concerns - Participate in preliminary root-cause analyses (RCA) and propose preventive measures Collaboration & HSE - Work closely with Process Engineers, Shift Managers, and Quality Control to ensure smooth production flow - Support training of operators on chemical handling and process compliance - Ensure full compliance with HSE, MSDS, and PPE requirements in lab and production environments We are looking for a hands-on, detail-oriented chemist who thrives in a structured, safety-critical production environment and takes pride in precision, documentation, and chemical control.
. • Identify risks and contingencies and partner with project leader in problem solving and resolution efforts. • Report to and relate with Trial Leader to provide updates, exchange critical information and share trial conduction information, within regulatory and compliance burdens. • Participate in and actively drive organizational, quality and process improvement initiatives to commence future leading change.
As Chief Chemical Engineer / Manager, you will be the scientific authority for solid propellant production and a key leader in our production organization. You will have two direct reports (chemists/technologists) and report to the Chief Production Officer (CPO) based in Vojens, Denmark. Your main responsibilities will include: Own the chemistry of our solid propellants – develop, document, and validate all fuel formulations and recipe control standardsDefine and maintain critical process parameters (temperature, mixing time, vacuum, catalysts, etc.) and ensure robust process windows from lab scale to full-scale productionLead and manage the analytical laboratory: raw material testing, in-process testing, test methodologies, calibration, documentation, and data traceabilityDrive recipe change control – plan and execute pilot batches, validation, and transfer to production, including updates of SOPs and work instructionsConduct root-cause analysis in collaboration with Process Engineering and Maintenance to address recurring defects, quality deviations and process instabilityEnsure full batch traceability and strong HSE practices for hazardous materials (classification, storage, transport, and safe handling)Collaborate closely with Quality Control to define sampling plans, acceptance criteria and CAPA activities (Corrective and Preventive Actions)Contribute to supplier qualification and material approval, including definition and verification of technical specificationsContinuously improve yield, scrap rate and recipe cost through optimization of formulations and process parametersMaintain and prepare documentation for ISO, AQAP and defense-quality audits related to chemical operationsLead, coach, and develop your team of chemists and technologists and help build a strong safety- and quality-driven culture on site We are looking for an experienced and hands-on chemical leader who thrives in a high-tech, safety-critical production environment and enjoys building something new.
As Chief Chemical Engineer / Manager, you will be the scientific authority for solid propellant production and a key leader in our production organization. You will have two direct reports (chemists/technologists) and report to the Chief Production Officer (CPO) based in Vojens, Denmark. Your main responsibilities will include: Own the chemistry of our solid propellants – develop, document, and validate all fuel formulations and recipe control standards Define and maintain critical process parameters (temperature, mixing time, vacuum, catalysts, etc.) and ensure robust process windows from lab scale to full-scale production Lead and manage the analytical laboratory: raw material testing, in-process testing, test methodologies, calibration, documentation, and data traceability Drive recipe change control – plan and execute pilot batches, validation, and transfer to production, including updates of SOPs and work instructions Conduct root-cause analysis in collaboration with Process Engineering and Maintenance to address recurring defects, quality deviations and process instability Ensure full batch traceability and strong HSE practices for hazardous materials (classification, storage, transport, and safe handling) Collaborate closely with Quality Control to define sampling plans, acceptance criteria and CAPA activities (Corrective and Preventive Actions) Contribute to supplier qualification and material approval, including definition and verification of technical specifications Continuously improve yield, scrap rate and recipe cost through optimization of formulations and process parameters Maintain and prepare documentation for ISO, AQAP and defense-quality audits related to chemical operations Lead, coach, and develop your team of chemists and technologists and help build a strong safety- and quality-driven culture on site We are looking for an experienced and hands-on chemical leader who thrives in a high-tech, safety-critical production environment and enjoys building something new.
Documentation,Traceability & Compliance • Maintain full traceability of inspected items, datasets, images, and reports in line with internal procedures and defense-grade standards. • Ensure high documentation quality and audit readiness; support audits, investigations, and internal reviews related to NDT and product integrity.