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.
Impel Talent is partnered with a fast growing, dynamic pharmacuetical company dedicated to revolutionizing the accessibility of biologics medicines. As a purpose-driven organization, they provide high-quality, cost-competitive biosimilars to patients around the globe.
They are expanding their manufacturing team for a brand new facility (12,500 m²), doubling their current capacity. The new extension will accommodate biosimilar development, drug refills, offices, and warehouses.
Be a part of their 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 them?
- 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 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.
- Proficient in upstream processes for the production of ATMPs.
- Hands-on experience operating downstream processing equipment.
- Expertise in purification 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 temporary housing.
- Competitive base salary based on seniority and experience.
- Shift allowance.
- Comprehensive training in purification activities, from protein A chromatography to freeze operations, following relevant protocols and batch records.
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.
Contact Information: To apply or for more information, please contact Impel at madeline.jarra@impeltalent.com
