Job summary
This role involves leading the development and optimization of scalable manufacturing processes for pharmaceutical diagnostic products, ensuring readiness for new product introduction and managing lifecycle changes. The position requires close collaboration across multiple departments to support technology transfer, process validation, and continuous improvement initiatives in a global manufacturing environment. Occasional international travel is expected.
Location and work setup
- Location
- Oslo
- Work setup
- On-site
Responsibilities
Lead and document development and optimization of manufacturing processes from early development to commercial production. Provide hands-on support for new product introductions and lifecycle modifications. Drive and document technology transfers and process validation activities. Collaborate with R&D, Quality, Regulatory Affairs, Manufacturing, engineering teams, and external vendors to ensure equipment and processes meet required standards. Analyze process data to enhance performance and robustness. Prepare and review scientific documentation to support regulatory submissions. Lead investigations including deviations, root cause analysis, risk assessments, and implement corrective actions. Ensure cGMP compliance and support audit readiness.
Qualifications
Master’s or PhD in Chemistry, Chemical Engineering, Pharmacy, or related field. Experience in GMP pharmaceutical environments, especially in drug product development, solutions, and filling processes. Strong knowledge of process development, scale-up, validation, and CMC lifecycle management. Ability to work independently and in global matrix organizations with strong analytical and problem-solving skills. Familiarity with contract manufacturing organizations, technical transfer processes, regulatory submissions, and lean methodologies. Willingness to travel internationally 10-20%.