Drug Product Lead Parenteral Iron

We are looking for a DP Lead parenteral Iron, to join our team in Zurich or St. Gallen, Switzerland. As part of the Integrated Product Team Iron & Small Molecules within Technical Operations, you will be responsible the scoping and execution of technical work packages related to CMC Development, Continuous improvement, and Technology Transfer of parenteral pharmaceutical products and manufacturing processes, as well as providing continuous MS&T support to external partners and CMOs to support routine manufacturing operations. The main focus will be on our iron-based parenteral products.

Key Responsibilities

• Scoping of technical work packages for different types of projects (e.g. CMC Development, Tech Transfer, Continuous Improvement) by defining technical implementation strategies, deliverables and technical risks
  
• Contribute to and review project execution plans (e.g. technical transfer plans)
  
• Execute DP related project work packages and tasks as subject matter expert for aseptic and terminally sterilized parenteral products manufacturing as per the project plan

• Qualification in natural/life sciences or associated engineering degree (i.e. Biology, Biochemistry, Chemistry, Pharmaceutics, etc.), Bachelor/Master level or equivalent
  
• Minimum 5 years experience in the pharmaceutical industry, direct experience in full scale commercial manufacturing (compounding, aseptic filling, sterilization, CCIT/Visual inspection) of parenteral products for intravenous application
  
• Self-driven and fast learner with the ability to take ownership execute work packages and tasks independently in a matrix organization
  
• Confident and proactive team player who collaborates effectively while working autonomously.
  
• Solid expert knowledge in sterile and aseptic fill & finish CMC development, Equipment -/Process Qualification & Validation, Manufacturing
  
• High Flexibility and willingness to travel & Experience in External Manufacturing Environment
  

• Familiarity with GMP requirements and Guidelines related CMC LCM activities, including Annex 1
  
• Preferably, experience with non-transparent solutions
  
• Know-how across various parenteral product primary packaging solutions (vials, ampoules, infusion bags)
  
• Experience in other Drug Product and Finished Product manufacturing & Technology Transfer, e.g. oral solid dosage forms
  
• Ability to work effectively in a multicultural and international environment
  
• Strong communication skills
  
• Analytical thinking & problem-solving skills
  
• Ability to adapt to changing project requirements.
  
• Languages: English fluently, German is an advantage