Senior USP MSAT Specialist – Upstream Processing

About the role

We are looking for a senior specialist to act as the subject‑matter expert for upstream processing in biologics manufacturing. The role will lead scale‑up, technology transfer and lifecycle management of commercial biosimilar products, ensuring robust, cost‑effective production in GMP environments.

Key responsibilities

• Provide technical leadership for upstream manufacturing processes and act as the SME for process scale‑up and technology transfer from development to GMP manufacturing.
• Deliver independent technical support, including process monitoring, troubleshooting and advanced data analysis to anticipate and resolve issues.
• Investigate deviations, perform root‑cause analysis and implement corrective and preventive actions (CAPA).
• Author, review and approve process and regulatory documentation such as PDDs, protocols, reports, change controls and submissions.
• Introduce, qualify and continuously optimise upstream processes in cGMP manufacturing, managing technical risk.
• Support lifecycle activities including Continued Process Verification, process changes and ongoing monitoring.
• Assess and qualify new materials, technologies and innovations to improve performance and efficiency.
• Collaborate with cross‑functional and cross‑site teams, ensuring compliance with cGMP, regulatory and EHS requirements.

Required profile

• Master’s degree in Life Sciences (Biotechnology or related field).
• 5–10 years of experience in the biopharmaceutical industry with a focus on upstream processing, process development or manufacturing.
• Strong knowledge of monoclonal antibody manufacturing and industrial biotechnology.
• Hands‑on experience in GMP environments and regulatory compliance.
• Proven ability to work independently, manage complex technical challenges and lead cross‑functional teams.

Required skills

• Upstream processing
• Process scale‑up
• Technology transfer
• cGMP manufacturing
• Regulatory documentation
• Data analysis
• Root‑cause analysis and CAPA
• Process optimisation and continuous improvement
• Material qualification

What we offer

• Opportunity to work on ambitious projects that impact patients’ lives.
• International, diverse and inclusive work culture.
• Support for personal growth and internal career development.
• Flexible and innovative work environment.