
Senior Biotechnologist, Upstream Operations
IS10 Alvotech hf · Reykjavik Headquarters, Iceland, United States
About The Role
Are you an experienced biotechnology professional with a passion for manufacturing excellence, quality, and continuous improvement? At Alvotech , we are looking for a motivated and solution-oriented Senior Biotechnologist to join our growing Manufacturing team.
This is an exciting opportunity to play a key role in the production of high-quality biologic medicines in a dynamic, international environment. You will work alongside talented colleagues, contribute to innovative projects, and help ensure the reliable manufacture of life-changing therapies for patients worldwide.
Please note: This role requires working rotating day, evening, and night shifts.
As a Senior Upstream Biotechnologist, you will be responsible for supporting and executing upstream manufacturing activities while ensuring compliance with cGMP and EHS standards. In this role, you will act as a subject matter expert in fermentation, seed train processes, and media preparation, ensuring high technical standards and reliable execution within a cGMP environment. The ideal candidate brings strong problem‑solving abilities, deep process understanding, and a commitment to operational excellence.
Key Responsibilities
- Serve as the technical and operational SME for upstream processes, ensuring strong understanding and hands-on proficiency in all related activities.
- Spearhead and execute fermentation and seed train operations, ensuring accuracy, consistency, and adherence to process requirements.
- Function as the process SME for media preparation, ensuring correct preparation, handling, and documentation according to established procedures.
- Own and manage assigned QMS activities, including but not limited to: Deviations, CAPAs, and investigations, ensuring timely closure and high-quality documentation.
- Analyze and interpret process data, identify trends, and communicate observations that support process stability and improvement.
- Support technology transfer, validation, and scale-up activities by applying strong process knowledge and technical expertise.
- Actively troubleshoot technical issues and support the team in resolving operational challenges efficiently and accurately.
- Coach and mentor team members to strengthen technical competency and promote consistent operational excellence.
- Work in full compliance with cGMP, EHS, and all applicable site procedures.
- Perform operational activities in Grade CNC, D, and C environments as required.
- Complete all GMP documentation, including batch manufacturing records and logbooks, with accuracy and attention to detail.
- Maintain inspection readiness of upstream areas, equipment, and documentation at all times.
- Support internal and external audits, inspections, and cross‑functional initiatives as required.
- Follow all relevant SOPs, maintain required training status, and ensure procedures are applied accurately in daily work.
Qualifications
- BSc or higher qualification in Biotechnology, Engineering, or comparable with 3+ years of industry experience.
- Proven experience of collaborative team working.
- Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude.
- Able to work in shifts and non-working days when required.
- Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies.
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