On behalf of our client, a globally recognized pharmaceutical leader with multi-billion-euro investment backing, we are supporting the expansion of a cutting-edge manufacturing site in Bavaria. This site is set to become a center of excellence for breakthrough therapies in cardiovascular disease and oncology. With a robust pipeline of both small molecule and biologic assets, the company is driving innovation at scale.
We are currently seeking an exceptional candidate to join their team as Associate Director CMC - Drug Product (Small Molecules) (m/w/d), you will be a key driver in ensuring successful site launches. You'll lead the development and execution of technology transfer strategies, manage CDMO relationships, and align cross-functional teams across global operations.
Key Responsibilities:
* Lead site launch activities for small molecule drug products at internal and external manufacturing sites.
* Develop and implement technology transfer strategies for solid oral and parenteral formulations.
* Serve as the primary technical liaison between development, manufacturing, and CDMOs.
* Review and approve technical documentation (e.g., PPQ protocols, validation reports).
* Scout and recommend CDMOs for clinical and commercial manufacturing.
* Ensure alignment with CMC strategy, regulatory requirements, and GMP standards.
* Support regulatory submissions (INDs, NDAs, MAAs) and respond to agency queries.
* Drive process validation, troubleshooting, and continuous improvement initiatives.
Your Profile:
* Ph.D. or Master's degree in pharmaceutics, chemistry, pharmaceutical technology, or a related field.
* Proven experience in small molecule drug product development, particularly in solid oral and/or parenteral forms.
* Strong knowledge of CMC development, technology transfer, and GMP compliance.
* Experience managing CDMOs and leading global tech transfer projects.
* Excellent communication and leadership skills in a cross-functional, international environment.
* Fluent in English; German is a plus.
What's in It for You?
* Make a real impact - Contribute to life-changing therapies that improve patients' lives worldwide.
* Be part of something bigger - Join a collaborative team where success is built on shared goals and mutual respect.
* Grow with purpose - Thrive in a culture that values continuous learning, innovation, and the power of diverse perspectives.
* Shape the future - Bring your ideas to life in a dynamic environment with a strong pipeline of exciting projects.
* Build from the ground up - Play a key role in the launch of a brand-new, cutting-edge production site.
* Live and work in Bavaria - Enjoy the quality of life in one of Germany's most beautiful and vibrant regions.
* Recharge and refresh - Benefit from 30 days of annual holiday to maintain a healthy work-life balance.
Die Personalberatung SThree betreut die ausgeschriebene Stelle im Auftrag ihres Kunden.