Impel Talent is excited to announce a strategic partnership with Alvotech for the hiring of over 40+ biotechnologists. We are working with the Head of USP to build a highly qualified team of manufacturing experts.
Alvotech is dedicated to revolutionizing the accessibility of biologics medicines. As a purpose-driven organization, 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 a 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 Upstream Operations team and play a crucial role in upholding the highest standards of compliance and safety. Act as a subject matter expert for USP processing steps and take charge of leading and coordinating deviation investigations.
Why Join Us?
- Innovative Environment: Work in a state-of-the-art facility that emphasizes 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: Ensure the USP suite and equipment are always inspection-ready and provide expertise in USP processing steps.
- 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 USP team. Train, coach and mentor less experienced members of staff to achieve a multi-skilled and engaged USP 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.
- Proficient in upstream processes for the production of ATMPs.
- Hands-on experience in operating upstream processing equipment.
- Knowledge/experience of cell culture principles, techniques, scale up, technology transfer and
- process validation activities.
- 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 in cell culture and upstream processes, following relevant protocols and batch records.
- 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 Impel Talent’s Madeline Jara at madeline.jarra@impeltalent.com
