About the job
Alvotech is dedicated to revolutionising the accessibility of biologics medicines. As a purpose-driven organisation, we provide high-quality, cost-competitive biosimilars to patients around the globe. This is a chance for you to be a part of a global and fast-growing company, to work with great co-workers on ambitious projects that change people’s lives, with an international work culture that encourages diversity, collaboration, and inclusion.
Our partnership with Impel Talent focuses on expanding our manufacturing team for our brand new facility (12,500 m²), doubling our current capacity. The new extension will accommodate biosimilar development, drug refills, offices, and warehouses.
Be a part of our dynamic Drug Product / Fill Finish team you will play a crucial role in upholding the highest standards of compliance and safety. Act as a subject matter expert perform recombination and pooling of drug substance; filling line set-up and sterile filling operations, equipment and line changeovers, and sampling in accordance with approved procedures prior to visual inspection activities.
Why Join Us?
- Innovative Environment: Work in a state-of-the-art facility that emphasises continuous improvement and operational excellence.
- Professional Growth: Take advantage of ongoing training, mentoring, and opportunities for career advancement, especially with our recent facility expansion.
- Impactful Work: Contribute to the production of high-quality biosimilars, making a tangible difference in patients’ lives.
Key Responsibilities:
- Subject Matter Expertise: Lead technical knowledge and experience in cleanroom operations incorporating recombination and pooling of Drug substance and aseptic filling
- Documentation: Serve as an SME author, reviewer, and/or approver for written procedures, SOPs, BMRs, and other cGMP documentation within your expertise.
- Technical Support: Assist in executing technical and validation protocols.
- Deviation Management: Lead and coordinate deviation investigations, identify root causes, and implement corrective actions.
- Quality Management: Ensure QMS records are initiated, progressed, and closed within company-defined KPIs.
- Technology Transfer: Support the technology transfer of processes to manufacturing scale.
- Supervision: Oversee manufacturing activities, ensuring adherence to cGMP standards.
- Mentorship: Coach and mentor new team members, fostering a skilled and engaged DSP team.
- Regulatory Interaction: Contribute to successful commercial Pre-Approval Inspections (PAIs), regular audits, and other regulatory interactions.
Requirements:
- 5+ years of experience in the Biopharmaceutical Industry, with biosimilar experience being advantageous.
- Degree in Biotechnology, Chemistry, or Bio/Chemical Engineering.
- Previous experience in a highly regulated sterile filling operation is required.
- Previous experience of syringe and vial sterile filling and visual inspection in a start-up environment is highly desirable.
- Experience supporting Pre-Approval Inspections (PAI) and working with international regulatory agencies, including the FDA and EMA.
Benefits:
- Full relocation support, including short term temporary housing.
- Competitive base salary based on seniority and experience.
- Shift allowance.
- Comprehensive training and opportunities for leadership development.
- Exercise and wellbeing support
Apply Now: If you are passionate about improving the accessibility of vital biologic medicines and want to be part of a pioneering team in a growing facility, apply now! Join us on our mission to make a global impact in the biopharmaceutical industry.
True to our Icelandic roots, we also believe that integrity, gender equality, and fairness are foundational. We strive to bring together the brightest minds regardless of backgrounds and beliefs, to deliver to our partners and patients around the world. Let’s create a healthier world together, through affordable biologic medicines.
Contact Information: Apply here or for more information, please contact Impel Talent’s Uri Lourenco at uri.lourenco@impeltalent.com .
