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Stillingsbeskrivelse
As a Manufacturing Development Scientist, you will provide scientific and technical expertise to support the development, scale-up, and lifecycle management of manufacturing processes across the Pharmaceutical Diagnostics (PDx) portfolio.
You will contribute to New Product Introduction (NPI) readiness and lifecycle product changes by executing manufacturing strategies aligned with CMC and regulatory requirements. Working cross-functionally with Manufacturing, Quality, Regulatory Affairs, and R&D teams, you will enable robust technology transfer, process validation, and continuous improvement.
This role plays a critical part in ensuring reliable product supply, compliance, and delivery of high-quality medicines to patients globally. This role is based at our manufacturing site in Oslo and requires some travel to other PDx manufacturing sites globally.
Essential Responsibilities
- Lead and document the development and optimization of robust, scalable manufacturing processes, contributing from development through preclinical and clinical phases to commercial manufacturing.
- NPI & Lifecycle Management: Provide hands-on manufacturing support for NPI and lifecycle changes.
- Technology Transfer & Scale-Up: Lead, support, and document execution of technology transfers and process validation activities.
- Cross-Functional Collaboration: Collaborate with R&D, Quality, Regulatory, and Manufacturing teams including Engineering and vendors to design and qualify equipment that is fit for purpose and aligns with process needs.
- Process Monitoring & Continuous Improvement: Analyze data to improve process performance and robustness.
- Documentation & Regulatory Support: Prepare, review and deliver suitable scientific documentation as subject matter experts to support regulatory submissions (IND, IMPD, NDA, MAA, etc.).
- Investigation & Problem Solving: Drive, lead, and document deviations, risk assessments, GAP/root cause analysis and CAPA implementation.
- Provide validation expertise, prepare validation documentation including cleaning validation.
- Compliance & Quality: Ensure cGMP compliance and support audit readiness and follow up.
Krav
- MSc or PhD in Chemistry, Chemical Engineering, Pharmacy or related field.
- GMP pharmaceutical experience in drug product development, drug product solutions, drug product filling processes including inspection, MSAT, or technical operations.
- Knowledge of process development, scale-up, validation, and CMC lifecycle.
- Self-driven, independent, strong analytical skills and ability to work in global matrix environments.
- Experience with CMOs, Technical Transfer, Regulatory submissions, and Lean/Operational Excellence.
- Willingness to travel internationally (10-20%).
Ferdigheter
Erfaring
mid-level