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Senior Director and Head of Project- and CMO Management, CMC Biologics

 
Requistion ID:  2497
Location: 

Copenhagen, Hovedstaden, DK

Date:  22-Nov-2021
 

Senior Director and Head of Project- and CMO Management, CMC Biologics

 

Description: A Global, Cross-organizational role

We are looking to add a Head of Project- and CMO management to our CMC Biologics team. The candidate should have extensive experience within project- and CMO management, and a broad knowledge within general CMC disciplines like process development, analytics, and manufacturing of drug substance and drug product. As Head of the Project- and CMO management team you will be overall responsible for the strategic leadership and management of pharmaceutical development activities in support of our growing Biologics pipeline - spanning from pre-IND stage through process validation and commercialization. You will lead a team of skilled Project Leaders that drive scientific processes from pre-clinical projects to late-stage and commercial projects. You will oversee the progress and pace of CMC project milestones, and you will support effective communication across CMC stakeholders inside and outside of our organization. You are expected to manage a global PM/CMO team and, finally, to define and maintain tactical plans and short/mid-term "must wins" for each CMC project based on an overarching roadmap set in collaboration with Head of CMC Biologics.

 

In Lundbeck, we strive to develop new innovating treatments to help improve the lives of the patients suffering from brain diseases. CMC Biologics support the development of new Biologics drug candidates for diseases like Migraine, Parkinson’s, and Alzheimer’s. Established CMC Biologics focus teams and working groups are responsible for the continued development of Lundbeck’s Biologics candidates and are working into global project teams with representatives from R&D, Preclinical and Clinical Development, Regulatory Affairs, and Commercial.

 

CMC Biologics is a global unit working with global CMOs. We are approximately 100 colleagues split between Lundbeck Headquarters in Copenhagen and Lundbeck Seattle Biopharmaceuticals. Our CMC Biologics organization is built on three strong pillars: A Center of Excellence for Process Development, Biologics Late stage Development & Production, and Project & CMO Management. In the Lundbeck Seattle Centers of Excellence, we have established laboratories and capabilities within all areas of process development, technology transfer, manufacturing, and process characterization and validation. Biologics Late stage development and production capabilities are established in Copenhagen, while the Project & CMO Management is a global function with project leaders based in Seattle and Copenhagen.

As Head of Project- and CMO Management in CMC Biologics you will play a key role in facilitating the collaboration between the teams in Copenhagen and Seattle, and you will set strategic directions for CMC development projects together with leaders in Copenhagen and Seattle. This job is a unique opportunity to join Lundbeck’s CMC area and be part of defining our path forward within biopharmaceuticals.

 

Your job and key responsibilities

  • Leadership of a global CMC team with highly skilled and experienced project leaders/managers
  • Ensure seamless collaboration between team members in located in Copenhagen and Seattle
  • Install effective PM practices to manage PMs and stakeholders across geographies
  • Be an active player in the development of the overall- and project specific CMC strategies and operational plans, taking all the CMC development phases towards successful BLA into consideration
  • Leading role in the selection of CMOs to support pre-commercial and commercial production of Bulk drug substance and drug product
  • Ensure strategic and technical CMO relationships are built and developed
  • Ensure flexible planning matching the shifting project demands over time, including scenario planning
  • Serve as a role model for effective and transparent communication with all levels across the company and aligning key stakeholders within and outside of the CMC function
  • Define strategic directions for CMC development projects together with leaders in Copenhagen and Seattle

 

Qualifications

  • Ph.D. with 15+ 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
  • Extensive experience with area budgets, project specific budgets, and the general resource budget and allocation process
  • Extensive experience in defining and implementing overall CMC strategies
  • Broad knowledge of technologies and processes for pharmaceutical production
  • Demonstrated ability to manage complex projects in a setup where CMOs/alliances were involved
  • Demonstrated solid R&D leadership and management experience with strong capability to inspire, engage, and achieve results
  • Experience with regulatory submissions, CMC technical sections of submissions and interacting with global regulatory authorities on technical matters
  • 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 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

 

Further information

For further information, please contact Vice President, Torben P. Frandsen (+ 45 3083 2452 or TOPF@Lundbeck.com).

Your application and CV should not be sent via email.

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

 

Your application

Please click on the link below to apply for the job. Applications will be reviewed ongoingly and must be sent no later than 8th December 2021.

 

 

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.