Senior Specialist, USP MSAT
On-site · Reykjavík, Capital Region, Iceland
Reykjavík, Capital Region, IcelandOn-siteFull TimeSenior LevelMasters DegreeLarge
Type
Full Time
Level
Senior Level
Education
Masters Degree
Company size
Large
Job Summary
Lead upstream process support, scale-up and lifecycle management for commercial biosimilar products as USP MSAT Specialist; acts as SME for upstream manufacturing, oversees process transfers from development to GMP manufacturing, analyzes data, investigates deviations, CAPAs, and supports CPV and lifecycle changes.
Required Qualifications
- Master’s degree in Life Sciences (Biotechnology or related field)
- 5–10 years of experience in the biopharmaceutical industry, with a focus on upstream processing, process development, manufacturing, or MSAT
- Strong knowledge of monoclonal antibody manufacturing and industrial biotechnology
- Experience in GMP environments and regulatory compliance
- Proven ability to work independently, manage complex technical challenges, and lead cross-functional teams
- Experience leading process scale-up and technology transfer from development to GMP manufacturing (clinical and commercial)
- Ability to author, review, and approve process and regulatory documentation (PDDs, protocols, reports, change controls, regulatory submissions)
- Experience with process monitoring, troubleshooting, and advanced data analysis
- Capability to investigate deviations, perform root cause analysis, and implement CAPAs
- Experience with CPV and lifecycle management activities
- Collaborate across cross-site teams and drive technical solutions and project delivery
- Compliance with cGMP, regulatory, and EHS requirements
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