H. Lundbeck A/S 010 - Research and Development

Lundbeck is a global pharmaceutical company specialized in psychiatric and neurological disorders. For more than 70 years, we have been at the forefront of research within neuroscience. Our key areas of focus are depression, schizophrenia, Parkinson's disease and Alzheimer's disease.

An estimated 700 million people worldwide are living with psychiatric and neurological disorders and far too many suffer due to inadequate treatment, discrimination, a reduced number of working days, early retirement and other unnecessary consequences. Every day, we strive for improved treatment and a better life for people living with psychiatric and neurological disorders – we call this Progress in Mind.

Read more at www.lundbeck.com/global/about-us/progress-in-mind.

Our approximately 5,000 employees in more than 50 countries are engaged in the entire value chain throughout research, development, production, marketing and sales. Our pipeline consists of several late-stage development programmes and our products are available in more than 100 countries. Our research centre is based in Denmark and our production facilities are located in Denmark, France and Italy. Lundbeck generated revenue of DKK 17.2 billion in 2017 (EUR 2.3 billion; USD 2.6 billion).

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


 

Senior Specialist for Upstream Process Development


An exciting- and cross-organizational role
We are looking to add a new Senior Specialist with strong experience within upstream process development and manufacturing to our CMC Biologics team. The team is responsible for the strategic- and technical leadership of pharmaceutical development activities in support of our biologics pipeline - spanning from pre-IND stage through process validation and launch. As a Senior Specialist, you will join focus teams responsible for the development for our biopharmaceutical drug candidates and you will work closely with colleagues responsible for the development of drug substance, drug product and analytical methods with the aim of achieving project objectives and global registrations for our biopharmaceutical drug candidates.
CMC Biologics is a small, but growing division within Chemical and Pharmaceutical Research (CPR) located in Lundbeck Headquarters in Valby. CPR supports the development of new drug candidates within depression, schizophrenia, Parkinson’s disease and Alzheimer’s disease. We strive to develop new innovating treatments to help improve the lives of the patients suffering from these diseases.
The CPR area employs altogether about 100 employees with a minority of these working on CMC Biologics projects. This job is a unique opportunity to join the CMC area and be part of defining the Lundbeck path forward within biopharmaceuticals.

Your job and key responsibilities

  • Ensure appropriate technical-, scale up- and production strategies incl. timelines are in place to meet clinical-, regulatory- and commercial supply needs
  • Be an active player in the development and execution of the project specific CMC strategy and operational plans taking all the CMC development phases towards successful BLA into consideration
  • Be an active member of the CMC FTs (Focus Team) and contribute to the progression of the projects in close collaboration with the other CMC FT members and other parts of Lundbeck.
  • Manage and work closely with external CMOs – ensuring proper oversight to ensure projects are completed on time and within quality- and budget expectation.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.

 Qualifications

  • Ph.D with 5+ years of experience in the biologics-, pharmaceutical/biotech industry
  • Extensive pharmaceutical development experience of biologic entities
  • Extensive experience with upstream process development including DOE based optimization
  • Experience with mammalian and microbial process development and manufacturing
  • Extensive experience with scale-up and transfer of manufacturing processes
  • Demonstrated ability to manage complex projects preferably in a setup where CMOs are involved
  • Experience with production and process characterization and validation of antibodies and/or therapeutic vaccines
  • 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 Senior Director, 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 23rd January 2019.

 
 

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Region:
Region Hovedstaden

Job type:
Permanent

Working hours:
Full-time

Working days:
Day

Application deadline:
23/01/2019

Location:
Copenhagen

[ Send application ]

Contacts:
Torben P. Frandsen
Mobile: +45 30832452

Company homepage:
http://www.lundbeck.com