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QA Academic for CMC development within biopharmaceuticals

The Company

Lundbeck A/S is a research based pharmaceutical company aiming at becoming a world leader in psychiatry and neurology, thereby improving the quality of life for patients suffering from psychiatric and neurological disorders. The key areas include: mood and anxiety disorders, schizophrenia, bipolar disorder, addiction disorders, Alzheimer’s disease, Parkinson’s disease, Huntington's disease and epilepsy. We also recommend visiting the company website www.lundbeck.com

The Chemical and Pharmaceutical Research (CPR) organisation is responsible for the CMC development and innovation of new drug candidates within depression, schizophrenia, Parkinson’s disease and Alzheimer’s disease. They strive to develop new innovating treatments to help improve the lives of the patients suffering from these diseases. CMC QA is responsible for the quality assurance in CPR and the team consists of 6 highly skilled colleagues, working with both small molecules and biopharmaceuticals.

Lundbeck is now expanding the CMC QA department and is looking for a skilled and experienced

QA Academic with focus on biopharmaceuticals.                               

QA Academic for CMC development within biopharmaceuticals                                  
With potential for more                      
     

  • Worldwide leading company within psychiatry and neurology
  • QA related to development and release of API & IMP for clinical studies
  • Close collaboration with CRO, CMO and external partners
  • You are development oriented and like to create results

The Challenge.

In this exciting position as QA Academic in CMC QA, you will have the opportunity to collaborate with    colleagues across the organisation, advising in quality matters related to development of biopharmaceuticals, including manufacturing of API/IMP, analysis, packaging and distribution of IMP. You will have a central role as expert within biopharmaceuticals and the possibility to obtain and maintain knowledge within specific quality topics and ensure this is communicated and implemented accordingly.

CMC QA is also responsible for releasing Active Pharmaceutical Ingredients (API) and Investigational Medicinal Products (IMP) for clinical studies for both small molecules and biopharmaceuticals and you will have the opportunity to becoming QP delegate, if you are not already trained in this.

You will be providing leadership for the quality assurance activities in support of the development pipeline and have a broad professional collaboration cross the organisation. You will also be a central part of the development of the quality system and of driving improvements within the organisation.

You will work with preparation of quality agreements and supplier evaluations and collaborate with CROs, CMOs and business partners. 

Being responsible for conducting external audits of CROs and CMOs in EU, US and Asia, travelling 4-5 times per year. You will also be conducting internal audits assuring the compliance with GMP/GDP requirements.

Lundbeck is offering you a challenging opportunity in a headquarter based position in one of the largest completely CNS focused research organisations. You will be giving the chance to work with some of the worldwide leading scientists. If you are a proactive, development oriented person, who likes to put your mark on the biopharmaceuticals area, this could be your next assignment. The position is based in Valby, Copenhagen, reporting to Manager, QP delegate CMC QA

Your Talent

You hold an MSc within pharmaceutical science, engineering or another relevant scientific discipline. You have solid knowledge and have been working with antibodies and biopharmaceuticals coming from QC, QA, formulation, CMC development or production. It is not necessary that you have been working within QA already, but you must have the interest and personality to work accordingly to GMP standards.

  • You have several years of experience from a similar position or working in a GMP area within CMC development of antibodies and/or biopharmaceuticals in the pharmaceutical industry
  • You are experienced in conducting quality audits
  • You possess drive, good collaboration skills and a positive mindset
  • You are motivated by driving improvements and embrace challenges and you are capable of inspiring your colleagues and the teams you work in, even when facing obstacles
  • You are fluent in spoken and written English and understand written Danish
  • You have proven strong ability in leading cross functional projects
  • You must be able to work effectively in an exciting busy, dynamic and global environment, able to adapt to different situations and short deadlines

Application

Best Talent is responsible for your employment at Lundbeck and review your application on a confidential basis. Forward your application including your CV marked ”1608/ QA” by way of e-mail to job@besttalent.dk or Best Talent, Rungstedvej 41,2970 Hørsholm. You can read more about Best Talent on www.besttalent.dk.

Closed for applications Gem job

Arbejdssted

Valby

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