Senior Biotechnologist, Downstream Operations
Alvotech · Reykjavik
Job description
About the role
Alvotech is seeking a Senior Biotechnologist to lead downstream manufacturing activities in a cGMP‑compliant environment. The role involves operating advanced bioprocessing equipment, ensuring product quality, and maintaining inspection readiness across multiple shifts.
Key responsibilities
- Execute downstream processing steps including Protein A chromatography, ion‑exchange chromatography, viral inactivation, filtration and tangential flow filtration (TFF) in Grade CNC, D and C cleanrooms.
- Perform formulation, bulk filling, freeze‑storage and final product release activities.
- Author, review and approve SOPs, batch manufacturing records and other GMP documentation as a subject‑matter expert.
- Support technical studies, engineering runs, validation protocols and regulatory inspections (PAI, audits).
- Participate in investigations, identify root causes and implement corrective and preventive actions (CAPA).
- Mentor and coach team members, driving continuous‑improvement initiatives.
Required profile
- 3‑5 years of experience in biopharmaceutical manufacturing or related biotechnology environment.
- Demonstrated ability to work independently and collaboratively in a fast‑paced production setting.
- Strong ownership, initiative and willingness to take on additional responsibilities with limited supervision.
- Willingness to work rotating day, evening and night shifts.
Required skills
- Protein A chromatography
- Ion‑exchange chromatography
- Viral inactivation and filtration
- Tangential Flow Filtration (TFF)
- Formulation and bulk filling
- Freeze‑storage operations
- Cleanroom operation (Grade CNC, D, C)
- cGMP and EHS compliance
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Published 1 month ago
Expires 2 weeks from now
22 views · 0 interested
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Alvotech
Reykjavik