Beschreibung
Analytical Development Manager (m/f/d)
Reference: -en
Start: asap
Duration: 12 MM+
Main tasks:
- Select and manage providers of analytical services including analytical services embedded in contract manufacturing organizations (CMOs)
- Provide analytical oversight of external vendors for API and finished dose CMC analytical activities for small molecule drug substance (DS) and drug product (DP)
- Design and oversee the development, validation and transfer of phase appropriate analytical methods for raw materials, in-process control, DS and DP testing and ensure the availability of all required documentation
- Participate in the development and revision of product specifications, providing expert level guidance in accord with current regulatory requirements
- Draft and review CMC sections of regulatory submissions along with other functional groups
- Timely monitoring and evaluation of release and stability data from CMOs and CROs for GMP Compliance, potential out of specification, out of trend and method performance issues and supervise or conduct investigations and implement corrective actions as needed
- Actively contribute to CMC and project teams and ensure alignment of analytical activities with the project development plans
- Maintain familiarity with a full range of analytical techniques for characterization of pharmaceuticals including HPLC and GC with a variety of detection methods, wet chemical analysis, spectroscopic techniques, particle size analysis
- Understand chemical development, solid state development and formulation development to identify and document critical factors that impact method performance and/or analytical development activities and ensure the availability of necessary documentation
Main qualifications
- Education in chemistry, pharmacy or equivalent
- Profound experience in analytical development
- Experience in development and outsourcing of analytical methods and method validation is mandatory
- Knowledge of chromatography separation and method development HPLC, IC, GC, KF
- Experience in GMP, ICH guidelines
- Very good knowledge of English and German (oral/written)
- Careful execution of work, creativity, innovativeness and initiative
- Team orientation and team spirit
Main advantages:
- A highly motivated team and an open way of communication
About us:
With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.
My contact at Hays:
My contact person:
Christoph Schaub
Referencenumber:
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