Oncoinvent presents a unique opportunity to join an expanding pharmaceutical start-up with both R&D and production established in-house which enables both hands-on lab work as well as working with external partners.
The company has solid owners and is in a clinical phase with its lead product (Radspherin®) which is produced in Nydalen.
The candidates should be looking for the energy in a start up with the ambition to make a difference. Successful candidates should be flexible, team-oriented yet able to work independently, and be analytical and results oriented.
If you would like to send us an open application, please send your application and résumé to oncoinvent@oncoinvent.com
We are currently searching for an experienced CMC Regulatory Affairs Manager to strengthen the regulatory team in maintaining CMC dossier documentation in Oncoinvent’s key territories (EU and USA).
Oncoinvent AS is looking for a technical systems engineer to strengthen the EHS team at the company’s manufacturing facility in Oslo. The EHS team is responsible to follow up all EHS related tasks ensuring compliance through all systems and processes at the site in Oslo where the development, and GMP compliant production of radiopharmaceuticals takes place.
Oncoinvent AS Gullhaugveien 7 0484 Oslo Norway
We are currently searching for an experienced CMC Regulatory Affairs Manager to strengthen the regulatory team in maintaining CMC dossier documentation in Oncoinvent’s key territories (EU and USA).
The Regulatory Affairs Department primary objective is to drive the secure product development for Oncoinvent according to required standards and deliver according to ambitious milestone plans for the products under clinical development.
The department should be able to proactively engage with internal and external stakeholders and be a key resource for advising on clinical and product development strategy for the company. Experience in working with CRO’s is important.
This position is an exciting opportunity to work in an innovative and dynamic bio-technology start-up company and participate in the development of novel pharmaceuticals. The company has its lead product candidate Radspherin® in first-in-human/phase I studies. Radspherin® is a radiopharmaceutical designed to treat peritoneal carcinomatosis originating from ovarian cancer and colorectal cancer as the first indications.
The candidates should be looking for the energy and enthusiasm in a start-up company with the ambition to make a difference for patients worldwide.
Key responsibilities:
The main purpose of the CMC Regulatory Affairs Manager position will be the following areas:
Qualifications and experience:
The holder of this position should have the following documented qualifications and experience:
Location
The holder of this position will be based at Oncoinvent AS, Gullhaugveien 7, 0484 Oslo and reports to the Head of the Regulatory Department.
Application deadline: We are reviewing the applications on a rolling basis.
Please submit your application with a motivational letter stating “why Oncoinvent” and what you can contribute to the position as well as an updated CV. Application without this will not be reviewed further.
Contact: Bjørn Fuglaas, 90775752 – CEO, Life Science Partners AS
About Oncoinvent
Oncoinvent is a privately held Norwegian company based in Nydalen, Oslo. The company is committed to developing novel, innovative products to provide better treatment options for cancer patients.
The Oncoinvent team consists of 50 employees and the company anticipates further growth.
Oncoinvent holds a state-of-the-art manufacturing facility to produce drug products intended for use in pre-clinical and clinical trials. Clinical trials for Oncoinvent’s lead product, Radspherin® are ongoing. For further details on Oncoinvent see www.oncoinvent.com.
The facility holds a GMP certificate from the Norwegian Medical Agency. The approval provides the company with the necessary flexibility and capacity for manufacturing clinical trial material for both patients and trial sites, as well as developing the company further.The company’s lead product candidate Radspherin® is a novel alpha-emitting radioactive microsphere suspension designed for treatment of micro-metastatic cancers in body cavities. The radium-224 based therapeutic, Radspherin® has shown strong and consistent anticancer activity at doses being essentially non-toxic in preclinical studies. It is anticipated that the product can potentially treat several forms of micro-metastatic cancer.
The development programs of the pipeline of the company include targeted radionuclide therapy for treatment of various solid cancers. The main focus of discovery is on alpha-emitting radionuclides for treatment by regional administration of the drug in body compartments with disseminated solid tumours.
Oncoinvent AS is looking for a technical systems engineer to strengthen the EHS team at the company’s manufacturing facility in Oslo. The EHS team is responsible to follow up all EHS related tasks ensuring compliance through all systems and processes at the site in Oslo where the development, and GMP compliant production of radiopharmaceuticals takes place.
The position is an exciting opportunity to work in an innovative and dynamic start-up company and participate in the development of novel pharmaceuticals.
The successful candidate will, together with the EHS team, production team and other Oncoinvent staff, ensure compliance with all EHS including Radiation regulatory aspects in the development and production of radiopharmaceuticals at the Oslo site.
This position requires work with radioactive materials. A successful candidate is therefore expected to comply with radiation protection and other health and safety procedures during laboratory- and production scale experiments, and GMP production activities.
Key responsibilities:
Specifically, the responsibilities include:
Qualifications and experience:
The holder of this position should have the following documented qualifications and experience:
The following experience is desirable:
Location
The holder of this position will be based at Oncoinvent AS, Gullhaugveien 7, 0484 Oslo. The position will report to the Head of EHS.
Application deadline: We are reviewing the applications on a rolling basis.
Please submit your application with a motivational letter stating “why Oncoinvent” and what you can contribute to the position as well as an updated CV. Application without this will not be reviewed further.
About Oncoinvent
Oncoinvent is a privately held Norwegian company based in Nydalen, Oslo. The company is committed to developing novel, innovative products to provide better treatment options for cancer patients.
The Oncoinvent team consists of 50 employees and the company anticipates further growth.
Oncoinvent holds a state-of-the-art manufacturing facility to produce drug products intended for use in pre-clinical and clinical trials. Clinical trials for Oncoinvent’s lead product, Radspherin® are ongoing. For further details on Oncoinvent see www.oncoinvent.com.
The facility holds a GMP certificate from the Norwegian Medical Agency. The approval provides the company with the necessary flexibility and capacity for manufacturing clinical trial material for both patients and trial sites, as well as developing the company further.
The company’s lead product candidate Radspherin® is a novel alpha-emitting radioactive microsphere suspension designed for treatment of micro-metastatic cancers in body cavities. The radium-224 based therapeutic, Radspherin® has shown strong and consistent anticancer activity at doses being essentially non-toxic in preclinical studies. It is anticipated that the product can potentially treat several forms of micro-metastatic cancer.
The development programs of the pipeline of the company include targeted radionuclide therapy for treatment of various solid cancers. The main focus of discovery is on alpha-emitting radionuclides for treatment by regional administration of the drug in body compartments with disseminated solid tumours.
alfheim@oncoinvent.com
+47 464 40 045
Jan A. Alfheim is a business executive with over thirty years’ experience bringing product ideas and technology to the chemical and pharmaceutical markets, from product concept inception through discovery and development phases to final marketing campaign and launch.
With experience in research, project management, business development & partnering, company start-ups, and product launches, Alfheim comes from Nordic Nanovector ASA where he was Chief Executive Officer from 2011 until 2014 and Chief Operating Officer from 2014 to 2016. Prior to working at Nordic Nanovector, he has held various senior roles including Chief Business Officer at Clavis Pharma, President of StemPath Inc, Director of Business Development at Neurochem Inc and Project Director at Nycomed Imaging. Mr. Alfheim holds a MSc from Concordia University and a MBA from McGill University.