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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

Senior Regulatory Affairs Manager with key responsibility within CMC

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).

Technical Systems Engineer (EHS)

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.

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Oncoinvent AS Gullhaugveien 7 0484 Oslo Norway

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Senior Regulatory Affairs Manager with key responsibility within CMC

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:

Responsibility for compiling, reviewing, updating and maintaining the drug substance and drug product dossier documentation for regulatory submissions.
Supporting change procedures for the manufacturing process.
Maintaining company’s up-to-date knowledge of regulatory requirements and secure implementation across teams.
Cooperation with regulatory consultants
Support of regulatory submissions for clinical trials and marketing authorization applications

Qualifications and experience:

The holder of this position should have the following documented qualifications and experience:

Life Science/Pharmacy degree in relevant discipline. An advanced degree
(MSc/PhD).
Minimum of 5-7 years of CMC specialized regulatory experience.
Experience with international applications for clinical trials and marketing authorizations.
Practical experience from any area within Chemistry, Manufacturing and Control would be advantageous.
Experience with cancer drugs and/or experience with radiopharmaceuticals would be advantageous.
Strong writing and communication skills. Fluency in English, both oral and written.
A successful candidate has a demonstrated ability to deliver on challenging goals and have relevant scientific competence. The ability to work well with others, have a systematic – and an analytical approach will be appreciated.

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.

Exiting position in growing Life Science company - Technical Systems Engineer (EHS)

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:

Proactively maintain the operational status of radiation monitoring instruments linked to the GMP production-, QC and R&D rooms.
Proactively support and perform maintenance of all instruments, equipment and ventilation units, supporting daily operation of the laboratories and production rooms at Oncoinvent.
Schedule and perform periodic calibration including GMP qualification of relevant production systems together with the production department. In doing so, minimize the impact on ongoing, clinical production.
Liaise with external parties to ensure that service and requalification activities are completed on time.
Summarise the service and GMP status of Oncoinvent’s manufacturing asset in an annual report. Periodically communicate the service and GMP status to key stake holders in Oncoinvent.
Support in the investigation and closure of deviations. Aid in the implementation of Corrective and Preventative Actions (CAPA). Initiate, lead and conclude compliance relevant activities such as risk assessments, change controls and root-cause investigations.
Support the radiation protection group in the procurement of new equipment and instruments.
Proactively seek and identify opportunities for continuous improvement with respect to HSE and GMP compliance.
Develop and maintain a working knowledge in radiation protection and participate in internal training of others on practical radiation protection.
Develop and maintain a working knowledge in Good Manufacturing Practice (GMP) and participate in annual GMP training.
This position will require work with radioactive materials. The holder of this position is therefore expected to comply with radiation protection and other health and safety (HSE) procedures during service, maintenance and GMP requalification activities.
The right candidate may also take an IT role managing instrument controllers and systems.

Specifically, the responsibilities include:

Radiation monitoring instruments
Oncoinvent’s ventilation systems, including fans and associated filters, as well as gasses such as pressurized air and nitrogen.
All equipment linked to safety equipment including gloveboxes, biosafety cabinets, drain pumps as well as small bench-top equipment and centrifuges.
Be the system owner of Oncoinvent’s environmental monitoring system (EMS) for the laboratories. Responsible for calibration of sensor, system maintenance and reporting. Together with users and management secure correct use and follow-on the system.

Qualifications and experience:

The holder of this position should have the following documented qualifications and experience:

Bachelor, high school degree in science- or a technical relevant discipline.
Working knowledge in Norwegian and English.
1-3 years practical, hands-on experience in the production of pharmaceuticals.

The following experience is desirable:

Familiarity with GMP regulations is an advantage.
Knowledge on systems maintenance is preferred, including monitoring systems and radiation monitoring devices.
A successful candidate will have to be able to work in a multidisciplinary team while being able to plan and perform practical work independently.
The development and production of radiopharmaceuticals is highly regulated, and a successful candidate will be selv-driven, with an attention to detail and expected make sound decisions based on scientific knowledge of relevant regulations.

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.