CMC Project Lead (f/m/d)

If you’re passionate about changing lives for the better, this is the opportunity you’ve been waiting for. In Research & Development, we’re continuously exploring innovative new treatment options to make a stronger, more positive impact on the lives of the patients we serve. You’ll work with talented colleagues in a state-of-the-art Research & Development environment, developing innovative medicines that change the live of patients for the better and help us make progress towards our vision of a world free of pain. Join us today, and discover the difference you can make.

What the job looks like
Each day you'll enjoy a variety of challenges, such as:
 

• Lead global CMC drug development projects from candidate profiling until successful regulatory approval and transfer to commercial manufacturing in a fully outsourced setting
• Define targets and strategy for CMC drug development with a focus on analytical development related activities
• Oversee the external execution of CMC drug development and manufacturing activities
• Lead scientific discussions on analytical development and testing topics with external service providers and internal stakeholders
• Define specifications for drug products, drug substance, excipients, starting materials, and raw materials in alignment with the CMC program team and in compliance with regulatory requirements and internal policies
• Review analytical procedures, validation plans and reports generated by external service providers
• Generate and oversee CMC project plan and budget
• Manage CMC project risks including project analyses and elaboration of mitigation actions
• Represent CMC function in global program team to provide input into the global program strategy and development plan, as necessary
• Facilitate exchange of project information and alignment with all relevant internal and external stakeholders
• Establish alliance management with commercial and internal partners ensuring an effective cooperation

What you'll bring to the table
To make the most of this role and truly thrive:

• University master degree and PhD preferably in Chemistry or Pharmacy
• At least 5-10 years of experience in the technical development of innovative pharmaceutical products
• Strong scientific background in analytical method development and validation, ideally for both, drug substance and drug product
• Broad experience over all phases of drug development and product registration is a plus 
• Passionate and experienced in project leadership and cooperating with external partners
• Proven ability to effectively communicate through and work in a matrix organization in a multinational company
• Excellent communication, negotiation and conflict management skills
• Broad international/intercultural working experience
• Fluency in (business) English, German language skills is a plus

______________________________________