Zentrale Ansprechperson für PAT-Messtechnik in Deinem Betreuungsbereich, verantwortlich für Implementierung, Dokumentation, Projektleitung und Instandhaltung von Prozessanalysensystemen an drei NRW-Produktionsstandorten.
Locations (3)
Dormagen, North Rhine-Westphalia, Germany
Leverkusen, North Rhine-Westphalia, Germany
Uerdingen, North Rhine-Westphalia, Germany
Compensation
attraktive Einstiegsvergütung zwischen 77.600 €/Jahr und 93.900 €/Jahr zzgl. eines variablen Anteils
Responsibilities
Sicherstellung der „License to Operate” durch korrekte Implementierung sicherheits- und umweltrelevanter Analysemessungen
Dokumentation der PAT-Installationen und Einhaltung interner sowie externer Richtlinien
Eigenverantwortliche Leitung von PAT-Projekten von Konzept bis Abschluss
Unterstützung der Instandhaltungsteams bei Störungen und Durchführung von Root-Cause-Analysen
Verantwortung für PAT-Owner-Rolle in Investitionsprojekten und Budgetplanung
Requirements
Bachelor, Master oder Promotion in Physik, Chemie oder Ingenieurwissenschaften
Leading the assessment and adoption of new analytical methods, Process Analytical Technology (PAT), and AI-enabled solutions for biologics and ADCs manufacturing.
Responsibilities
Lead evaluation and implementation of next-generation analytical technologies, rapid methods, and novel potency approaches to streamline control strategies.
Assess applicability of emerging methodologies for technology transfer, commercialization, lifecycle management, comparability assessments, and post-approval changes.
Implement Process Analytical Technology (PAT) to underpin Operations 2030 ambitions.
Deploy AI tools that streamline analytical knowledge management and enable Real-Time Release Testing.
Lead cross-functional initiatives and drive organizational change.
Requirements
Advanced degree (PhD, MS, or equivalent) in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or related scientific area
Process Development Engineer within the Manufacturing Sciences & Analytical Technology team in Bray, responsible for process engineering expertise and leadership supporting small molecule drug products.
Compensation
Base Salary Range: €57,800.00 - €79,420.00
Responsibilities
Lead technical transfers, NPI and material qualification projects
Manage process development, packaging development, validation and product lifecycle changes
Execute feasibility, process optimisation, hold-time and validation studies
Provide technical support for complex process issues, deviations and product investigations
Identify and implement improvements to increase yield, reduce processing time, defects and waste
Requirements
Bachelor's or Master's in Life Sciences, Engineering or a related field
Senior Scientist in the Analytical Commercialization Technology (ACT) group responsible for analytical development of late-stage pharmaceutical products.
Locations (2)
Rahway, New Jersey, United States
West Point, Pennsylvania, United States
Compensation
$117,000.00 - $184,200.00
Responsibilities
Utilize advanced analytical tools for problem-solving
Analyze data for technical insights and trending
Develop and validate robust analytical methods
Conduct drug product testing and analytical investigations in a cGMP environment
Characterize drug products and manufacturing processes
Requirements
PhD in Chemistry or related discipline
Master of Science in Analytical Chemistry or related discipline
Nice to have: Ultrahigh/High-Performance Liquid Chromatography (UHPLC/HPLC)
Participate in new product introduction including RFQ, DFM review, and NPI production planning. Execute process optimization, technical development projects, and maintain process documentation.
Responsibilities
Participate in new product introduction activities, including RFQ, DFM review, NPI production plans, and maintenance of new product mass production checklists.
Execute process optimization and task-based projects, including expansion plans, process improvement, technology development projects, and cross-plant improvement activities.
Maintain process documents and system data, including SOP, OCAP, PFMEA, CP.
Responsible for pre-mass production audits and process support, including audits for various models, factory support audits, and tracking mass production introduction issues.
Support process exchange and anomaly handling, including training, on-site process problem solving, RMA analysis, and process anomaly analysis.
Associate Director, Analytical TechnologyAstraZeneca · Chennai, India
Senior Scientist - Analytical Commercialization Technology (ACT)Merck · Rahway, US+1 more
M10393 SiP製程工程師WNC Corporation (formerly Wistron NeWeb Corporation) · Hsinchu, Taiwan