About this role
Íslenska:
Vilt þú verða hluti af Drug Substance Operations teyminu hjá Alvotech í Reykjavík og starfa í öflugu og faglegu umhverfi þar sem nákvæmni, gæði og samvinna skipta máli?
Við leitum að jákvæðum og lausnamiðuðum einstaklingum sem eru tilbúnir að takast á spennandi áskoranir. Við bjóðum upp á vandaða þjálfun, góða handleiðslu og tækifæri til að vaxa í starfi.
English
Overview of role:
Join the Drug Substance Operations Team at Alvotech in Reykjavik and be a part of a dynamic, highly regulated environment where attention to detail and thoroughness are key. We're seeking individuals who are proactive, embrace challenges and have a positive mindset. The role requires extensive training, and Alvotech prioritizes teaching, mentoring, and guiding its technicians. Working in day/evening/night shifts is required.
Key Responsibilities:
- Perform all activities in full compliance with current Good Manufacturing Practices (cGMP) and Environment, Health & Safety (EHS) standards, ensuring work is executed in a safe and compliant manner. Demonstrate willingness to take on additional tasks under appropriate supervision.
- Execute cGMP manufacturing activities within Grade CNC, D, and C classified areas, adhering strictly to aseptic and containment requirements.
- Aseptically culture mammalian cells in shake flasks through the completion of the production process using single-use bioreactor systems, in accordance with approved protocols.
- Prepare media and buffers to defined specifications following approved standard operating procedures and batch documentation.
- Proactively maintain the USP manufacturing suite and associated equipment in a perpetual state of inspection readiness, ensuring compliance with regulatory and internal quality standards.
- Actively participate as a reviewer of cGMP documentation within the individual’s area of expertise.
- Support the execution of technical studies and validation activities, including process and equipment qualification, under approved protocols.
- Support successful regulatory inspections, including Pre-Approval Inspections (PAIs), and routine audits.
- Demonstrate a strong commitment to operational excellence, continuous improvement, and right-first-time execution within the assigned functional area.
Qualifications:
- Bachelor’s or technical degree in biotechnology, chemistry, biochemistry, biochemical engineering, or science related fields (desirable)
- No prior experience required, but laboratory experience is a plus
- Proficiency in Microsoft Office programs (Word, Excel)
- Excellent command of English language
- Ability to multitask and work both independently and as part of a team
What we offer:
- An inspiring challenge to work with great co-workers on ambitious projects that change people's lives.
- The chance to be a part of a global and fast-growing company.
- An international work culture that encourages diversity, collaboration and inclusion.
- Positive, flexible, and innovative work environment.
- Support for personal growth and internal career development.
- Company social events and milestone celebrations.
- Excellent in-house canteen and coffee house.
- Exercise and wellbeing support for full-time employees.
- On-site shower facility.
- Transportation grant towards eco-friendly modes of travel for full-time employees.
- Internet at home for full-time employees.
About Alvotech
Icelandic biosimilar company developing and manufacturing high-quality biologic medicines for global markets. Based in Reykjavik.
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