Process Development Technologist

Oncoinvent ASA; Oslo; On-site; NOK 600,000 - 800,000; Full time

Job summary

A clinical-stage biotechnology company is seeking a Process Development Technologist in Oslo. The role includes optimizing manufacturing processes and ensuring compliance with regulatory standards. The ideal candidate has a relevant degree and experience in process development. This is an exciting opportunity to work in a dynamic environment focused on innovative cancer therapies.

Qualifications

• Degree in Biotechnology, Chemical Engineering, or related fields (M.Sc. or Ph.D.).
• Experience in process development, scale-up, or manufacturing support.
• Strong understanding of manufacturing processes, in particular suspensions and microparticles.
• Familiarity with GMP and regulatory requirements.
• Proficiency in data analysis, process modeling and experimental design.
• Norwegian and English language skills.

Responsibilities

• Transfer laboratory-scale and pilot-scale processes to commercial manufacturing scale.
• Optimize process parameters while maintaining product quality.
• Collaborate with cross-functional teams to transfer processes into GMP production.
• Ensure processes comply with regulatory and quality standards.

Skills

Process development

Scale-up experience

Problem-solving

Cross-functional collaboration

Data analysis

Communication

Education

Degree in Biotechnology or Chemical Engineering (M.Sc. or Ph.D.)

Job description

Overview

Oncoinvent AS is looking for a Process Development Technologist in the Production department at the company manufacturing facility in Oslo. 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 Process Development Technologist is responsible for translating laboratory-scale processes into robust, efficient, and commercially viable production processes. The role involves upscaling, optimization, and continuous improvement of production methods to ensure high-quality, cost-effective, and compliant manufacturing. Working closely with the other functional units and Contract Manufacturing Organisation (CMO’s), the technologist bridges the gap between development and full-scale commercial operation.

The successful candidate will collaborate with cross-functional teams and be responsible for ensuring that the production methods of the raw materials, intermediates and drug product (Radspherin) are developed into commercially viable processes.

This position may require hands-on work with radioactive materials. A successful candidate will therefore receive extensive training and is expected to comply with radiation protection and other health and safety procedures during laboratory- and production scale experiments, and GMP production activities.

Responsibilities

• Process Upscaling: Transfer laboratory-scale and pilot-scale processes to commercial manufacturing scale.
• Process Optimization & Improvement: Optimize process parameters while maintaining product quality through data-driven approaches. Look for continuous improvement opportunities.
• Technology Transfer & Implementation: Collaborate with cross-functional teams to transfer processes into GMP production. Support validation, qualification, and troubleshooting activities.
• Commercial Readiness: Ensure processes comply with regulatory and quality standards (e.g., GMP, ICH guidelines) and with process control strategies suitable for long-term commercial operation. Participate in risk assessments and process failure mode analyses (pFMEAs).

Qualifications

• Degree in Biotechnology, Chemical Engineering, or related fields (M.Sc. or Ph.D.).
• Experience in process development, scale-up, or manufacturing support.
• Strong understanding of manufacturing processes, in particular suspensions, microparticles and preferably radiochemistry.
• Familiarity with GMP, regulatory requirements, and process validation principles.
• Proficiency in data analysis, process modelling, and experimental design.
• Strong problem-solving, communication, and cross-functional collaboration skills.
• Norwegian and English language skills.

Location

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

Application

Application deadline: We are reviewing candidates 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.

Oncoinvent is a clinical-stage biotechnology company developing novel radiopharmaceutical therapies against cancer. The lead product candidate, Radspherin, uses the alpha-emitting radionuclide radium-224, directly targeting micro-metastases post-surgery, harnessing the benefits of modern radiopharmaceuticals without the complexities of biological targeting. Oncoinvent is investigating the safety and efficacy of Radspherin in a clinical development program in two indications. In addition to the finalized phase 1/2a trial in colorectal cancer, one Phase 1 trial and one randomized Phase 2 trial, both in ovarian cancer are ongoing in the US, UK and Europe. Preliminary clinical efficacy data are highly encouraging, and no serious toxicity or safety concerns have been reported to date. The Oncoinvent team consists of approx. 40 employees and runs a state-of-the-art manufacturing facility to produce drug products for clinical trials in Nydalen, Oslo. Oncoinvent is listed on the Euronext Growth Oslo (ONCIN:OL).