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CMC Project Director

Location:  

Copenhagen, Hovedstaden, DK

Want to be part of leading one of our CMC projects and drive the biologics portfolio forward within Lundbeck?

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

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

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. In doing so, you will work closely with project teams consistent of SMEs and other professionals for upstream/downstream process and analytical development, tech transfer, GMP manufacturing, characterization, and validation. Furthermore, you will collaborate closely with our Quality and Regulatory team to ensure that our products going through development will be according to latest industry standards and regulatory guidance.

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.

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 structure, forming a collaborative working environment based on respect and equality. We create the ideal conditions for you and your job, so 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 and production of new Biologics drug candidates for diseases like Migraine, Parkinson’s, multiple system atrophy, and Alzheimer’s. CMC Biologics is responsible for the strategic- and technical leadership of pharmaceutical development in support of our growing Biologics pipeline - spanning from pre-IND stage through process validation and launch. Pipeline activities continue to grow, and the CMC Biologics team is expanding to maintain progress and we are now approximately 100 colleagues split between Lundbeck Headquarters in Copenhagen and Lundbeck Seattle Biopharmaceuticals.

The CMC Project Director position is based at our site in Copenhagen. This position entails frequent interaction with Seattle-based colleagues both through travel and online. We operate in a flexible hybrid model across time zones.

High level 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

 

Degrees of interest: Ph.D. with 10+ years of experience in the biologics-, pharmaceutical/biotech industry

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