mpel Talent is partnering with a leading global biopharmaceutical company to build a world-class Downstream Operations team. As part of a major expansion project, we are hiring a Downstream Supervisor to lead a team of 10 FTEs in a cutting-edge 12,500 m² state-of-the-art manufacturing facility.
This is a unique opportunity to lead a growing team, contribute to innovative biologic manufacturing, and play a key role in delivering high-quality, cost-effective biosimilars to patients worldwide.
Key Responsibilities
?? Supervise and lead a team of 10 downstream processing specialists, ensuring compliance with GMP, FDA, and EMA regulations.
?? Oversee day-to-day DSP operations, including chromatography, filtration, purification, viral clearance, and UF/DF processes.
?? Act as a subject matter expert (SME) for downstream processing steps, ensuring the facility and equipment are always inspection-ready.
?? Lead and coordinate deviation investigations, identifying root causes and implementing corrective actions.
?? Drive continuous process improvements, supporting technology transfer and process validation activities.
?? Contribute to successful Pre-Approval Inspections (PAI) and regulatory audits.
?? Mentor and train team members, fostering a skilled and engaged workforce.
What We’re Looking For
?? 5+ years of experience in Biopharmaceutical Manufacturing, with biosimilar experience preferred.
?? Degree in Biotechnology, Chemistry, Bio/Chemical Engineering, or related field.
?? Strong hands-on experience in downstream processing (DSP), including chromatography, viral clearance, filtration, and purification techniques.
?? Proven leadership skills, with experience managing a team in a GMP-regulated facility.
?? Ability to troubleshoot process deviations and implement effective solutions.
?? Experience supporting regulatory inspections (FDA, EMA, etc.).
Why Join?
? Full relocation support, including short-term temporary housing.
? Competitive salary + shift allowance.
? Work in a brand-new facility doubling manufacturing capacity.
? Comprehensive training in downstream processing and purification techniques.
? Join a mission-driven company making biologic medicines more accessible.
This is a confidential opportunity, and we are seeking highly skilled professionals ready to lead a growing team in a cutting-edge manufacturing environment.
?? Apply now to have a confidential discussion!
