Cmc Project Lead
vor 6 Monaten
**Country**:Germany**City**:Aachen**Department**:Research & Development**Job ID**:43623- 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:
- 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
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