To strengthen our team we, are seeking a dedicated scientist to represent the team and coordinate early and late phase programs. In this position, you are responsible for further developing the center of excellence (CoE) for particle counting for biotherapeutic finished products, bridging and coordinating laboratory analytics. Your scientific dedication and agility to work in a GMP-regulated development environment are essential to ensure robust and compliant applications and approaches. After a thorough on-the-job training, you will have responsibility for project coordination, method validations and transfers to manufacturing sites and commercial quality control laboratories, drafting regulatory submissions and supporting marketed products.
Your Responsibilities
Assume a leading role in project coordination and method validation of particulate assays for biotherapeutic programs (protein and cell and gene therapy products) representing the Particulates team as subject matter expert (SME).
Build on existing BSL-2 know-how and infrastructure to expand particle analytical portfolio for cell and gene therapy products
Coordinate activities pertaining to particle method validations and transfers in compliance with internal guidances and health authority expectations
Coordinate project-related tasks with our partners
Represent the particulates team in project meetings as particle subject matter expert (SME)
Writing scientifically sound technical documents
Compiling data for registration dossier
End-to-end understanding of business processes and ability to propose changes to strive for high efficiency
Highly motivated to work on novel technologies and scouting for new technologies
Work in a team-oriented environment and respect diversity and inclusion when interacting with partners and colleagues
Qualifications
For this position we are looking for a scientifically minded, flexible and team-oriented person with the following skills:
Minimum requirement: M.S. with at least 5 years’ experience or PhD with at least 2 years’ experience in life science, material sciences, analytical development or pharmaceutical development
Self-employed and entrepreneurial style
Curiosity and drive to deep-dive into scientific questions
Excellence in analytics, project coordination and presentation skills
Experience in authoring and reviewing technical content for regulatory submissions advantageous
Experience within the pharmaceutical or GMP-regulated industry preferred and knowledge of relevant GMP regulations for analytical laboratories
Excellent communication skills in English (written and spoken), German desired
We are offering you a multifaceted opportunity in a dynamic, international environment with attractive terms and career opportunities as well as a good infrastructure!
Required Skills
Preferred Skills
Analytical Reasoning, Biochemistry, Chemistry, Manufacturing, and Control (CMC), Coaching, Consulting, Critical Thinking, Drug Discovery Development, Emerging Technologies, Molecular Diagnostics, Pharmacogenetics, Pharmacovigilance, Process Improvements, Quality Assurance (QA), Relationship Building, Research Documents, Scientific Research, Technologically Savvy
