API Coordinator in API Development
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Do you want to use your professional expertise within drug substance process development and/or API manufacturing to drive and impact a variety of early and late stage development projects? In that case, you could be our new API Coordinator in Chemistry, Manufacturing & Control (CMC) API Development.
About the department
Your new department, CMC API Project Office, consists of 20 highly motivated employees located in Bagsværd and Gentofte. The department is involved in the entire portfolio of development projects moving through the clinical phases from early to late stage drug substance development and production of drug substance candidates. We strive to have a high level of scientific knowledge and a helpful and pleasant working environment.
The job
You will coordinate and lead all CMC API project activities through the different stages of clinical development, from Lead Candidate Selection to final regulatory approval. You will coordinate process development activities performed in our laboratories - this will typically include cell culture, recovery, synthesis, purification and drying manufacturing steps. The CMC API activities will also include establishment of new starting materials, planning of pilot scale manufacturing, development of upscaling for full scale manufacturing, authoring of regulatory documentation (e.g. Clinical Trials Application (CTA) and New Drug Application (NDA/MAA)) as well as writing and compiling of various internal and external documentation.
As an API Coordinator you will be a member of a CMC Project Core Team and you will lead a sub-project team focused on the API Development in an engaging and motivating way. The position will also give you the opportunity to collaborate with stakeholders within CMC Development and coordinate the transfer of project activities from our research unit to CMC Development and further on to our manufacturing unit Product Supply or to a CMO
Qualifications
You hold a PHD or a MSc in Pharmacy, Engineering or another relevant field within natural sciences. Your degree is supplemented with min. 4-6 years of experience where you have gained in-depth knowledge of working with drug substance process development and/or manufacturing in GxP regulated facilities as well as experience with project management. In particular, we expect you to have experience with upstream or downstream processing within yeast, mammalian or e-coli production processes.
On a personal level, you have a high level of energy to drive yourself and your colleagues forward. You are result-oriented and take pride in delivering on your milestones, and you motivate your colleagues with a positive, forthcoming attitude. You work well independently, although it also motivates you to cooperate with colleagues and stakeholders across functions and departments. Lastly, you must have fluency in written and spoken Danish and English.
Contact
For further information, please contact Niels Nørregaard Holst +45 30 75 81 16 from 2nd of January 2020.
Deadline
17th of January 2020
Millions rely on us
To work for Novo Nordisk you will need the skills, dedication and ambition to change lives for the better for millions of patients living with diabetes and other chronical diseases. In exchange, we offer the chance to be part of a truly global workplace, where passion and engagement are met with opportunities for professional and personal development.
Information og data
Denne ledige stilling har jobtypen "Projektleder", og befinder sig i kategorien "Ledelse og personale".
Arbejdsstedet er beliggende i Bagsværd.
Jobbet er oprettet på vores service den 17.12.2019, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
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