Scientist in Drug Product Development, Senior Expert Science & Technology(m/w/x)

Beschreibung

As a functional lead in Schaftenau, you will drive the scientific strategy for biologic drug products, overseeing everything from formulation and process development to global technology transfers.

Anforderungen

• •Ideal PhD or Master in pharmaceutical technology, biotechnology, chemical engineering or relevant discipline
• •Experience in biotech or pharmaceutical industry formulation, manufacturing, transfer, validation and submission
• •Understanding of pharmaceutical quality standards and regulations
• •Advantageous experience in Good Manufacturing Practice (GMP) environment
• •Proficiency in development concepts and quality principles
• •Interest in using innovative product development tools
• •Knowledge in data science and statistical data analysis
• •Advantageous expertise in process modeling, simulation, automation and basic programming
• •Strong scientific/technical writing and presentation skills
• •Open, curious, problem-solving mindset
• •Flexibility and willingness for continuous learning
• •Excellent oral and written English
• •Coaching skills and knowledge of Waterfall model

Aufgaben

• •Lead the scientific strategy for complex biologic drug product projects
• •Drive technical deliverables in partnership with project managers
• •Design and supervise scientific activities and experiments
• •Deliver development work packages within agreed timelines
• •Interpret results and present data to project sub-teams
• •Execute technology transfers to internal and external manufacturing sites
• •Write and review high-quality reports for regulatory submissions
• •Contribute to health authority interactions and audits as a subject matter expert
• •Lead root cause investigations and develop risk mitigation plans
• •Drive scientific initiatives and internal workstreams
• •Present technical results to internal and external audiences
• •Ensure technical excellence throughout the development program

Tools & Technologien

Benefits