NorthSea Therapeutics is seeking CMC Manager

NorthSea Therapeutics B.V

NorthSea Therapeutics B.V.(NST) is a Dutch biotech company focused on developing structurally engineered fatty acids (‘SEFAs’) for the treatment of NASH and other metabolic disorders. NST licensed the rights to its lead compound icosabutate and a library of SEFAs from Pronova BioPharma Norge AS, who developed Lovaza® (US brand, branded Omacor® in Europe), a blockbuster cardiovascular drug. Icosabutate has been found safe and effective in two prior phase 2 clinical studies for treatment of hypertriglyceridemia and mixed dyslipidemia and is currently in clinical development for NASH. The icosabutate phase 2b ICONA NASH trial is scheduled to readout in the first quarter of 2023. Two additional SEFAs are in clinical development; SEFA-1024 is in phase 1 to be developed for dyslipidemia, and SEFA-6179, entered phase 1 in December 2021, is being developed for the orphan indication IFALD, (Intestinal Failure Associated Liver Disease). NST is headquartered in the Netherlands with a presence in Norway and the US and is supported by Ysios Capital, Forbion Growth, Hercules Capital, Forbion Ventures, Novo Seeds, BGV, NSV, venBio Partners and Sofinnova investments. Find out more about us online at: www.northseatherapeutics.com

 

CMC Manager

M.Sc. in Analytical or Organic Chemistry  M.Sc. in Pharmacy
GMP  supply of drug product for clinical studies  drug development

NorthSea Therapeutics (NST) currently have three candidate drugs in clinical development and are searching for a CMC Manager to strengthen our team. We are seeking a team-oriented person, preferably with experience within pharmaceutical development. The main responsibility will be to support the development and manufacture of drug product with our contracting partners, and to support the analytical development in all projects.

Main areas of responsibility:

  • Plan and manage supply of drug product for clinical studies
  • Support analytical development
  • Steer and monitor our contract manufacturers and service providers
  • Manage projects according to plans
  • Review and approve technical documentation from our contractors
  • Write and review quality documents required to support regulatory submissions
  • Be a subject matter expert to support other internal functions

Education, experience and other qualifications:

  • M.Sc. in Pharmacy, Analytical or Organic Chemistry or similar
  • A few years of industry experience
  • Experience with/Interest in analytical chemistry
  • Experience with drug development
  • Knowledge of pharmaceutical regulations and guidelines
  • Experience from GMP
  • Good communication skills
  • Ability to work independently and as part of a team
  • Fluent in written and spoken English
  • Basic working proficiency in Norwegian

Location:

The position will be based in Nydalen, Oslo

Employment Type:

Permanent. Full-Time

Starting date:

ASAP

Questions and Application process:

This recruitment is carried out in collaboration with the executive search firm Borka Consulting AS.
Borka Consulting specializes in finding talented candidates in the Life Science sector in Norway, The Nordics and in Europe.

If you have any questions regarding NorthSea Therapeutics or the position, feel free to contact our recruitment advisors in Borka Consulting; Cecilie Fraas Borka at +47 928 55 352 or André Borka at +47 908 31 871.
Please send your application (both motivational letter and CV in PDF format) to cecilie@borka.no.
Norwegian applicants may apply in Norwegian. In the application letter, please highlight which of the above-mentioned “Education, experience and other qualifications» you fulfill.

All inquiries are treated confidentially, also towards NorthSea Therapeutics in the initial phase if desired.
Deadline for applications: April 18th.
The selection process may start before the application deadline, please send in your application as soon as possible. We reserve the rights to close the advert earlier. All applicants can expect feedback on the application.
We look forward to receiving your application!

For å søke på denne stillingen må du sende en e-post med CV og søknadsbrev til andre@borka.no

Del dette:
Facebooktwitterlinkedin