Description
CMC Lead Pharmaceutical Development (Interimsproject) (m/f)
Reference: -en
Start: asap
Duration: 5 MM++
Main tasks:
- You plan and execute the CMC strategy for new development products and manage the practical activities at the respective contract parties; this can include APIs and finished products
- You are strongly involved in CMC dossier preparation and authority registration processes of the CMC part (submission, deficiency process, life-cycle/variations)
- You are involved in contract negotiations/quality agreements and budget monitoring of your projects
- You will be part of the GMP audit team
- You work and collaborate with other CMC Leads in a dynamic team
- You ensure effective communication with external partners (CDMOs) and monitor subcontracted activities
- You are the CMC part in a global project management team and interact with internal stakeholders (e.g. clinics, RA, SCM, QM)
Main qualifications
- Natural science/scientific background (HTL, FH, university)
- Practical experience in CMC development of oral solid dosage forms or parenteral products (injectables, lyo) – formulation,manufacturing, analytics
- Profound operational pharmaceutical quality knowledge and reasonable implementation of GMP and CMC regulations/guidelines
- Strong communication and presentation skills in English and German
- IT skills (MS Office, Adobe Acrobat, alternatively MS-Project)
Main advantages:
- A very renowned company
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:
Anna-Elisa Hochreiter
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