Process Development Scientist

About the role

We are looking for a Process Development Scientist to support commercial biopharmaceutical manufacturing, focusing on formulation and aseptic filling. The role involves monitoring processes, troubleshooting issues, and driving continuous improvements while maintaining strict quality and regulatory compliance.

Key responsibilities

• Monitor and analyze formulation and aseptic filling processes.
• Troubleshoot manufacturing issues and support root‑cause investigations.
• Participate in deviation handling, investigations, and product impact assessments.
• Collaborate with cross‑functional teams to ensure safe and efficient operations.
• Prepare technical documentation for regulatory inspections and audits.

Required profile

• Ph.D. in a scientific discipline, or MSc with 2+ years, or BSc with 4+ years of relevant experience.
• Experience in a commercial biopharma manufacturing environment, especially formulation and aseptic filling.
• Strong understanding of protein science and formulation processes.
• Excellent written and verbal communication in English and Spanish.

Required skills

• Process monitoring and data trending.
• Data analysis using statistical software (e.g., JMP).
• Deviation investigation and root‑cause analysis.
• GMP‑regulated manufacturing support.
• Technical writing for regulatory documentation.

What we offer

• Opportunity to work on cutting‑edge biopharmaceutical products.
• Collaborative, cross‑functional environment.
• Professional development in a regulated manufacturing setting.