Job - Skilled - Recruitment Solutions GmbH
Aufgaben
- Responsible for a project portfolio of up to 4 small projects (typically up to phase 2) or 1-2 highly complex or late stage projects (typically phase 3 and commercial)
- Representation of AD/QC in technical project team and CMC team meetings
- Proficiency in immunizations, complex macromolecules, or antibody-drug combinations
- Development, optimization and implementation of analytical methods
- Carrying out release, repeat and stability studies, transfer and validation analyses
- Preparing source documents for IND, IMPD and NDA/MA submissions and responding to regulatory inquiries
- Creation and review of CoAs, analytical result sheets, specifications
- Contact for 3rd parties, e.g., CMOs and CROs, for defined analytical tasks
- Independent evaluation and development of novel analytical techniques and instrumentation
- Leverages workload of respective project members to assure timelines and budget are met
Qualifikationen
- Knowledge of GMP/regulatory requirements and a solid background in analytical chemistry required
- Experience in analytical development Project Management
- Basic knowledge of synthetic chemistry, processing of active ingredients and/or formulation development
- Development and implementation of analytical tests for various active ingredients and products
- Active search for technical and scientific solutions to improve quality and productivity
- Excellent problem solving skills and teamwork in diverse teams
À propos de l'entreprise
