Principal Scientist Process

Principal Scientist – Global Process, Biotherapeutic’s Drug Product Development and Delivery

Location:

Schaffhausen, Switzerland

• Lead late‑stage process development, technology transfer, process validation, and/or filing activities between manufacturing sites by providing scientific support and technical project management.
• Accountable for critical process development projects, developing and using lab‑based “scale‑down” models to evaluate process parameters and build knowledge of “scale‑up” of unit operations.
• Author tech transfer documents such as protocols, reports, criticality analysis and regulatory submissions.
• Support local or external manufacturers in troubleshooting parenteral products requiring scientific expertise.
• Act as subject matter expert for scientific aspects of fill/finish manufacturing of parenteral products during internal and external audits.
• Partner with cross‑functional groups to ensure processes align with J&J IM platforms and comply with CMC dossiers and cGMP regulations.
• Provide feedback to development teams on technical performance and consistency with the Janssen process development approach.
• Participate in parenteral networking to ensure seamless transfer of drug product manufacturing from lab through pilot to commercial scale.
• Contribute to defining scientific strategies for new product introductions for fill‑finish processes to external or internal manufacturers.
• Work independently with strong problem‑solving skills.

• Expertise in current and future manufacturing principles and processes, preferably applied to large‑molecule fill and finish.
• Demonstrated competency and experience in biologics drug product development within the biopharmaceutical industry.
• Knowledge of drug substance and/or drug product process, and applied experience of biopharmaceutical process design, technology transfer and drug product fill/finish operations.
• Experience with a variety of container‑closure systems including vials, syringes and applicable delivery devices.
• Proven track record of creativity and problem‑solving; ability to collaborate with cross‑functional teams.
• Excellent oral and written communication skills in German and/or English.
• Motivated self‑starter able to work independently.
• Degree – Master’s in Chemistry, Biochemical Engineering, Chemical Engineering, Pharmacy or a related field with at least 6 years of experience OR Ph.D. with at least 4 years of experience.

Travel: 10–30% – project dependent.

• Analytical Reasoning
• Biochemistry
• Biotechnology
• Chemistry
• Manufacturing and Control (CMC)
• Clinical Research and Regulations
• Clinical Trial Designs
• Coaching
• Critical Thinking
• Drug Discovery Development
• Emerging Technologies
• Molecular Diagnostics
• Organizing
• Pharmacovigilance
• Presentation Design
• Process Improvements
• Productivity Planning
• Scientific Research