Downstream Scientist, Manufacturing Product Support
On-siteCopenhagen, Capital Region, Denmark
Job Summary
Support production execution by creating, reviewing, and approving Master Production Records, while facilitating solutions and ensuring timely deviation closure during batch breakdowns. Manage batch documentation and root cause investigations to maintain error-free, compliant manufacturing processes. Coordinate multi-departmental tasks with QA, QC, Engineering, and Process Validation, and lead troubleshooting efforts for critical process steps. Provide on-call shopfloor support approximately 24 hours three times monthly to ensure continuous line availability. This role offers growth within a global CDMO team developing advanced biologics and cell therapies for commercial production.
Required Qualifications
- BSc or MSc from natural or life science related fields
- 2 years or more, working in a manufacturing team operating under cGMP
- experience writing, reviewing and approving GMP documentation
- trained in deviations
- basic understanding of CRs, CAPAs
- strong communication skills
- demonstrated experience in leading troubleshooting efforts
- self-motivated, organized and proactive
Desired Qualifications
- experience in a commercial GMP manufacturing
- experience working in a similar production support role with downstream process experience
- experience with operations of single-use technologies and aseptic processing
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