Oncoinvent AS is looking for a Senior Process Development Scientist in the Production department at the company manufacturing facility in Oslo. The position is an exciting opportunity to work in an innovative and dynamic clinical-stage biotech company and participate in the development of novel pharmaceuticals.

The Senior Process Development Scientist is responsible for leading process development studies from hypothesis to decision, and for translating laboratory-scale processes into robust, efficient, and commercially viable production processes. The role involves scale-up, 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 Organizations (CMOs), the scientist bridges the gap between development and full-scale commercial operation. The position will report to the Chief Production Officer.

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.

Key responsibilities

• Experimental Strategy & Design: Plan hypothesis-driven, risk-based studies using statistical design of experiments (DoE), linked to the pFMEA and process control strategy.
• Scale-up, Scale-down & New Technology: Apply scale-up and scale-down principles to take the Radspherin® process to Phase 3 and commercial scale, and evaluate new technologies such as single-use and filtration systems.
• Laboratory & Process Execution: Lead hands-on experimental work, equipment operation and troubleshooting, with sound sampling strategies, data integrity (ALCOA+) and radiation protection.
• Data Interpretation & Process Understanding: Turn statistical analysis, mass balances and mechanistic understanding of particle formation into evidence-based decisions.
• Investigations & Manufacturing Support: Lead root cause investigations and act as subject matter expert in deviations, CAPAs and GMP production.
• Technology Transfer & Regulatory Support: Transfer processes to GMP production and CMOs, author validation and development documentation, support regulatory submissions and inspections, and mentor Process Development Technologists.
• Engineering Projects: Act as process owner in radiopharmaceutical engineering projects, from user requirements and design review to equipment qualification.

Qualifications and experience

The holder of the Senior Process Development Scientist position should have the following documented qualifications and experience:

• M.Sc. or Ph.D. in Chemistry, Chemical Engineering, Galenic Pharmacy, Biotechnology, or related fields.
• At least 10 years of experience in process development, scale-up, or manufacturing support in the pharmaceutical or biotechnology industry.
• Extensive experience in a GMP-regulated environment, including process validation and technology transfer.
• Documented experience with statistical experimental design (DoE) and data analysis (e.g., MODDE, JMP, R, or Python). Experience with MVDA is an advantage.
• Documented experience leading projects and mentoring colleagues.
• Strong understanding of suspensions and microparticle-based systems. Experience with precipitation, crystallization, tangential flow filtration, radiochemistry, or CMC documentation (IMPD, IND Module 3) is a strong advantage.
• Analytical and structured mindset, with healthy skepticism toward own data and strong communication skills toward both scientific and management audiences.

Location
The holder of this position will be based at Oncoinvent AS, Gullhaugveien 7, 0484 Oslo. Some travel should be expected as part of the role.

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.