Vil du være med å bygge Life Science industrien i Norge?

Description
Oncoinvent AS is looking for a scientist to strengthen the production team at the manufacturing facility in Oslo. The production team at Oncoinvent is tasked with the development, and GMP compliant production of radiopharmaceuticals. The newly created 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 production team and other Oncoinvent staff, drive the manufacture and development of drug product for pre-clinical and early-phase clinical trials. However, the focus of the work will be the production of calcium carbonate microparticles for Radspherin®.
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:

• Routine, GMP compliant production of calcium carbonate microparticles and Radspherin® to supply clinical trials.
• Support the development and scale-up of the calcium carbonate microparticle production process.
• Planning, designing and conducting laboratory- and production scale experiments with the aim of increasing the yield and scale of a process for the production of calcium carbonate microparticles.
• Support the production- and R&D team during the development of new manufacturing processes and debottlenecking of existing processes, incl. troubleshooting of technical challenges.
• Write and review experimental protocols and reports. Document experimental procedures and results according to GLP and GMP guidelines.
• Write and review batch manufacturing records. Produce and document the production of pre-clinical and clinical drug product according to GMP.
• Review and analyze results from laboratory- and production scale experiments. Communicate results and findings to Oncoinvent’s staff and management team.
• Develop and maintain a working knowledge in Good Manufacturing Practice (GMP) and participate in annual GMP training.
• Help with maintaining the calibration and qualification status of Oncoinvent’s production facility, equipment and instruments.
• Support production, QC and QA in the investigation and closure of any deviations. Aid production, QC and QA in the implementation of Corrective and Preventative Actions (CAPA).
• If necessary, support and participate in internal audits and audits performed external, national or international regulatory bodies.
• Housekeeping and routine cleaning of GMP production rooms and general laboratory, including handling of radioactive and non-active waste.

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

• M.Sc. in chemical engineering, process chemistry or other relevant discipline.
• 1-3 years practical, hands-on experience in development and production of pharmaceuticals.
• Experience in solid-liquid separation and/or production of colloids.
• Familiarity with cGMP regulation and experience with working in clean rooms is an advantage.
• Working knowledge in Norwegian and English.
• The production of pharmaceutical is highly regulated, and a successful candidate will be expected to show a high attention to detail with respect to planning and documentation of practical work.
• A successful candidate will further have to be able to work in a multidisciplinary team, have a systematic and analytical approach with sound judgement while being able to plan and perform practical work independently.

Location
The holder of this position will be based at Oncoinvent AS, Gullhaugveien 7, 0484 Oslo. The position will report to the Head of Production.

Please submit your written application with a reference to "why Oncoinvent" and what your unique contributions would ble. Please feel free to contact me directly with any questions.
 

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 32 employees and the company anticipates further growth.
In December 2017 Oncoinvent finished building a state-of-the-art manufacturing facility to produce drug product intended for use in pre-clinical and clinical trials. Clinical trials for Oncoinvent’s lead product, Radspherin®, started in 2020. For further details on Oncoinvent see www.oncoinvent.com.
The facility received a GMP certificate from the Norwegian Medical Agency in February of 2019. 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.