CMC Project Director

Project Director for CMC Biologics, CMC

Join our community of specialists and take part in the journey towards restoring brain health

You have a unique opportunity to join our CMC Biologics team as Project Direct where you will define our path forward within biopharmaceuticals and drive biologics projects in a global and cross-organizational setting.

CMC Biologics is responsible for the strategic- and technical leadership of pharmaceutical development in support of Lundbeck’s growing Biologics pipeline - spanning from pre-IND through process validation and launch. As Project Director you will lead cross functional project teams responsible for driving and coordinating activities with internal partners and CMO/CROs to develop and manufacture our Biopharmaceutical drug candidates.

Why should you be part of our journey?

In Lundbeck, our commitment is embedded in our Danish heritage, our solid foundation ownership and our culture of innovation. To us, it is essential that Lundbeck is a place where you grow and thrive both personally and professionally. Lundbeck offers a great workplace that is based on a flat hierarchy, forming a collaborative working environment based on respect and equality. We create the ideal conditions for you and your job so that we can create better conditions for patients. Together, we are creating a brighter future for people living with brain diseases. That is our promise to each other and to the world.

The CMC Biologics team supports the development of new Biologics drug candidates for diseases like Migraine, Parkinson’s, multiple system atrophy, and Alzheimer’s. We are approximately 100 colleagues split between Lundbeck Headquarters in Copenhagen and Lundbeck Seattle Biopharmaceuticals. As Project Director you will play a key role in facilitating the collaboration between colleagues in Copenhagen and Seattle, and you will set strategic directions for CMC development projects together with our leaders.

The position will be based primarily at our site in Copenhagen but entails frequent interaction with Seattle-based colleagues both through travel and online. We operate in a flexible hybrid model across time zones.

Highlights from responsibilities

• Lead and manage cross-functional and cross-Atlantic CMC Project teams responsible for advancing CMC activities in our Biologics pipeline
• Represent CMC in the global project teams and ensure alignment between CMC and the other areas involved with the progression of the Biologics pipeline
• Manage, oversee, and work closely with external global CMOs to ensure that projects are completed on time and within quality- and budget expectations

Qualifications

• Ph.D. with 10+ years of experience in the biologics-, pharmaceutical/biotech industry
• Strong scientific background and extensive experience within CMC and drug development throughout the biotech value chain
• Demonstrated excellent Project Management capabilities within CMC development activities of biologics along with extensive experience in defining and implementing overall CMC strategies
• Demonstrated ability to manage complex projects in a setup where CMOs/alliances were involved
• Experience with regulatory submissions, CMC technical sections of submissions and interacting with global regulatory authorities on technical matters, including knowledge of FDA, EMA and ICH guidelines and regulations governing CMC development
• Excellent collaboration skills and the ability to work as a team player in a multidisciplinary global environment
• Strong interpersonal- and communication skills, well-organized, consistent, and goal driven
• Drive, a positive mindset, and the ability to embrace challenges when facing obstacles

Want to learn more?

For further information, please contact hiring manager, Senior Director, Klavs Kirk (+45 30833406 or KLKI@Lundbeck.com).

Your application and CV should not be sent via email.

We also recommend that you have a look at our website LinkedIn and Instagram.

Sounds interesting?

Please click on the link below to apply for the job. Applications will be reviewed on an ongoing basis and must be sent no later than 04 April 2022.

Lundbeck is a global pharmaceutical company specialized in brain diseases. For more than 70 years, we have been at the forefront of neuroscience research. We are tirelessly dedicated to restoring brain health, so every person can be their best. 

Billions of people worldwide live with brain diseases – complex conditions often invisible to others that nonetheless take a tremendous toll on individuals, families and societies. We are committed to fighting stigma and discrimination against people living with brain diseases and advocating for broader social acceptance of people with brain health conditions. Every day, we strive for improved treatment and a better life for people living with brain disease.  

We have approximately 5,600 employees in more than 50 countries, and our products are available in more than 100 countries. Our research programs tackle some of the most complex challenges in neuroscience, and our pipeline is focused on bringing forward transformative treatments for which there are few, if any therapeutic options. We have research facilities in Denmark and the United States, and our production facilities are located in Denmark, France, and Italy. Lundbeck generated revenue of DKK 17.7 billion in 2020 (EUR 2.4 billion; USD 2.7 billion). 

For additional information, we encourage you to visit our corporate site www.lundbeck.com and connect with us on Instagram (h_lundbeck), Twitter at @Lundbeck and via LinkedIn.  

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