Mfg Scientist II

Luterbach , Soleure, Switzerland

Type: n/a

Category: Healthcare & Pharma

Requirements: English
Company: TN Switzerland
Region: Luterbach , Soleure

The Mfg Scientist II will provide key technical leadership for materials and analytics of clinical and commercial manufacturing campaigns at the Solothurn Drug Substance manufacturing facility. You will be part of the Global Manufacturing Sciences group.

You will lead raw material investigation, forensics, and analytics in the Manufacturing Sciences Laboratory and establish or extend data system applications for material trending, analysis, and genealogy. This position supports material-related facility fits, process transfer activities, and campaign readiness in cross-functional teams for new production introduction, process validation, lifecycle management, and regulatory commitments. The role also extends into USP or DSP Process Transfer & Sciences team activities as per internal organization and workload.

What You''ll Do

1. Lead raw material forensics capabilities at the Solothurn Manufacturing Sciences laboratory. Maintain and extend analytical equipment and methods, support laboratory operations, and guide junior team members.
2. Provide technical expertise to operations by leading resolution of raw material investigations, performing impact assessments, and leading CAPA & GCC implementation.
3. Lead material-related facility fits, process transfer activities, campaign readiness, and projects to improve facility capabilities, process understanding, robustness, and efficiency. Extend into USP & DSP as per organizational needs.
4. Establish and extend data system applications for raw material data trending, analysis, and genealogy.
5. Author and review technical protocols and reports. Support regulatory audits and meet regulatory filing & RtQ commitments. Ensure clear communication and escalation of results.

Who You Are

You have experience leading raw material investigations, forensics, and analytics at a Drug Substance facility. Your role involves managing lab operations, supporting process transfers, and ensuring manufacturing campaign readiness. You have developed data systems for material trending to improve process efficiency and have provided expertise during regulatory audits.

Qualifications

• PhD, MSc, or BSc in Biochemistry, Chemistry, Chemical or Bioprocess Engineering, Biology, or related field.
• BS with at least 8 years of experience
• MS with at least 4 years of experience
• PhD with at least 2 years of experience
• Identify opportunities for process improvements and implement changes.
• Deep understanding of process descriptions, control strategies, and process technology.
• Proficient with operational quality concepts and quality management systems.
• Knowledge of manufacturing execution systems (e.g., Syncade and Delta V) and extended biotechnology processes.
• Implement cGMP improvements and ensure compliance with cGMP and good documentation practices.

Additional Information

Why Biogen?

We are a global team committed to excellence and innovation. As a mid-sized biotechnology company, we offer stability and resources, fostering an environment where individual contributions significantly impact our mission to deliver life-changing medicines. Our talented team provides opportunities for growth and skill expansion. We work together to care deeply, achieve excellence, and change lives.

At Biogen, we value inclusion and diversity, reflecting the communities we serve. We believe diverse backgrounds, cultures, and perspectives strengthen us and drive innovation. We are dedicated to building teams where every employee feels empowered and inspired. Learn more about our DE&I efforts.

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