Jobbeschreibung
Peppercorn - talent acquisition. For more than 30 years, we support our clients in the personnel recruitment for fixed and temporary placements. We are a financially independent company within the FAVORIS group.
For an international pharmaceutical company located close to Basel we are looking for a:
CMC Expert - Late Stage Projects (f/m/o) 100%
Your tasks:
Responsible for executing CMC development projects at late stage. Managing cross functional projects involving internal stakeholders and CMO/CROs. Lead and outsource activities at CMOs/CROs. Write Common Technical Documents (CTDs) - Module 3, communicate on CMC related questions with HAs regarding registration strategy (Type C meeting). Participate to due diligence.
Your profile: Ideally 15+ years of experience in the pharmaceutical industry covering different roles in CMC (chemistry, manufacturing and control) with solid knowledge in Formulation, Manufacturing, Analytical Development and Regulatory.
Master Degree in Pharmaceutical Chemistry or Pharmaceutical Technology Pharmaceutical development and manufacturing professional with 15+ years experience at innovator and/or CMO companies. Expert in drug product technical development of injectables dosage forms such as liquid and lyophilized parenteral, up to and including commercial drug products. Accomplished leader of multi-disciplinary CMC (chemistry, manufacturing and control) team with development and commercial projects responsibilities. Solid regulatory knowledge to assume responsibility for module 3 preparation of the NDA dossier. Experience in pre-approval inspection preparation. Competent in late stage large and small molecules and fill-finish operations including hands-on experience in process tech transfer of peptides. Extensive experience of contracting, operational management and supply chain strategy with Contract Development and Manufacturing Organizations. Ability to work in an established team as well as having independent thinking skills. Knowledge of early and late phase solid dose formulation development. Direct experience in manufacturing areas and profound GMP knowledge.
Extra Informationen
- Status
- Inaktiv
- Ausbildungsniveau
- Andere
- Standort
- Allschwil
- Arbeitsstunden pro Woche
- 4 - 40
- Jobart
- Vollzeitstelle
- Tätigkeitsbereich
- Verkauf / Retail
- Führerschein erforderlich?
- Nein
- Auto erforderlich?
- Nein
- Motivationsschreiben erforderlich?
- Nein
- Sprachkenntnisse
- Deutsch
