Analytical Project Lead

vor 4 Wochen


Ulm, Deutschland SGK-Life Sciences Vollzeit

**Analytical Project Lead(m/w/d)**

*
IHRE AUFGABEN:*
- Management and coordination of all analytical topics within the projects as Analytical Project Lead (establishing analytical and control strategy, transfers, validations,)
- Following advances in the area of RNA therapies, recent developments in the field, proposing state of the art technologies.
- Representation of QC in internal and external teams and outcoming tasks (exchange of information, cascading decisions, budgeting, definition of QC work packages, timelines )
- Management of complex tasks, timelines, coordination of stakeholders from different departments and with cooperation partners, contract laboratories
- Preparing and review of submission documents (e.g. pre-IND, IMPD, DTA, MA)
- Representation of Quality Control at cooperation partners, authorities

**IHR PROFIL**:

- Completed studies in the natural/life sciences (preferably PhD in e.g. pharmacy, (technical) biology, biotechnology, chemistry, medicine or comparable)
- Several years of professional experiences, preferably as a project manager in the biotechnological or pharmaceutical industry (ideally in GMP area)
- Good knowledge of project management, as well as regulatory requirements (AMWHV, Ph.Eur., international GMP regulations)
- Knowledge in the areas of pharmaceutical analysis, molecular biology, qualification/validation, method transfer, risk assessments & management
- Basic knowledge of risk assessment strategies
- Very good communication skills in German and English
- Strong ability to work in a team
- Skilled user of PC and IT tools

**SGK LIFE SCIENCES CONSULTING**:
Wir sind eine inhabergeführte Unternehmens
- und Personalberatung der Life Sciences Industrie und der Gesundheitsbranche. Schwerpunkte sind die spezialisierte Personalrekrutierung, die Vergütungsberatung und die Entwicklung von Karrieremodellen für wissenschaftlich getriebene Unternehmen.
Wir freuen uns über Ihr Interesse und Ihre Kontaktaufnahme per Mail oder telefonisch.
**UNSER ANGEBOT**:

- You will be part of an exciting company
- attractive salary
- several benefits
- innovative culture


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