Associate Director CMC Manufacturing Technologies (temporary eplacement)

Mainz, Germany | full time | Job ID:9211

As a key member of our global CMC team, the Associate Director of CMC Manufacturing Technologies plays a crucial role in overseeing phase-appropriate requirements concerning raw materials and excipients. This includes authoring and maintaining gap assessments for specific products, as well as managing relevant Quality by Design (QbD) documents such as Critical Material Attributes (CMA) and Critical Quality Attributes (CQA) templates. As an experienced professional, you will train, guide, and support members of project-specific CMC teams. Please note: This position is a temporary replacement for 18 months and cannot be offered on a permanent basis.

• Oversee the development and maintenance of material-related QbD documents, including CMA and CQA templates.
• Collaborate effectively with internal and external teams to ensure compliance with material requirements in a phase-appropriate manner throughout all clinical phases leading up to BLA and MAA submission.
• Support CMC teams to ensure fulfillment of all material requirements (phase-appropriate) with main focus on individualized RNA therapeutics.
• Drive continuous improvement of processes for assessing and procuring of raw materials and excipients.

• A degree in a scientific or engineering field; advanced degree preferred.
• Minimum of 5 years of experience in the pharmaceutical or biotech industry, with at least 3 years specializing in materials.
• Profound knowledge of GMP regulations and biopharmaceutical manufacturing requirements, particularly related to materials.
• Expertise in QbD approaches with an emphasis on materials.
• Exceptional communication and interpersonal skills for fostering strong relationships with both internal and external stakeholders.
• Ability to work independently and prioritize tasks in a fast-paced, dynamic environment.
• Strong intra-cultural expertise and fluency in English, written and verbally.

It's our priority to support you:

• Your flexibility: flexible hours | vacation account
• Your growth: Digital Learning | Performance & talent development | leadership development | Apprenticeships | LinkedIn Learning
• Your value: Your voice at the table | Culture on an equal footing | Opportunities to shape & impact | Support for your full potential
• Your health and lifestyle: Company bike
• Your mobility: Job ticket | Deutschlandticket
• Your life phases: Employer-funded pension | Childcare