Principal Scientist Process Full-time

Principal Scientist

Johnson&Johnson's Innovative Medicine is recruiting for a Principal Scientist in the Global Process, Biotherapeutic's Drug Product Development and Delivery organization, located in Schaffhausen, Switzerland.

At the Johnson & Johnson Innovative Medicine, what matters most is helping people live full and healthy lives. We focus on treating, curing, and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.

The candidate for this position will be responsible for process development and technology transfer of fill/finish manufacturing processes of biotherapeutic products. The candidate will also work and partner with colleagues in MSAT, Quality, Regulatory, and other functions to ensure the implementation of manufacturing processes that meet all regulatory requirements and expectations.

Primary responsibilities:

• Lead late-stage process development, technology transfer, process validation, and/or filing activities both to and between manufacturing sites (internal/external network) by providing scientific support as well as technical project management.
• Accountable for critical process development projects. Develops and uses lab based “scale-down” models to evaluate process parameters and ranges and builds knowledge of “scale up” of unit operations to confirm or modify understanding of critical and key parameters.
• Responsible for timely authoring of tech transfer documents (e.g. protocols and reports, criticality analysis and regulatory submissions).
• Supports local or external manufacturers in troubleshooting parenteral products requiring scientific expertise.
• Acts as subject matter expert for scientific aspects of fill/finish manufacturing of parenteral products during internal and external audits.
• Partners with cross functional groups to ensure processes are consistent to accepted J&J IM platforms and are in compliance with the submitted CMC dossiers and general cGMP regulations.
• Provides feedback to development teams about technical performance and consistency with the Janssen process development approach.
• Participates in parenteral networking to ensure a seamless transfer of drug product manufacturing processes from lab through pilot to commercial scale.
• Contributes to defining scientific strategies to new product introductions for fill finish processes to external or internal manufacturers.
• Ability to work independently.

Qualifications:

• A technical expert on current and future manufacturing principles and processes, preferably with an application to large molecules fill and finish.
• Demonstrated competency and experience in biologics drug product development within the biopharmaceutical industry is required.
• Must have knowledge of drug substance and/or drug product process.
• Knowledge and applied experience of biopharmaceutical process design, technology transfer and drug product fill/finish operations is a must.
• Experience with a variety of container-closure systems including vials, syringes and applicable delivery devices is preferred.
• Proven track record of creativity and problem solving.
• Ability to collaborate with cross functional teams is a must.
• Excellent oral and written language skills in German and/or English.
• Motivated, self-starter able to work independently with demonstrated problem-solving skills.

Degree: Master Degree in Chemistry, Biochemical Engineering, Chemical Engineering, Pharmacy or a related field with at least 6 years of experience OR a PhD in Chemistry, Biochemical Engineering, Chemical Engineering, Pharmacy or a related field with at least 4 years of experience is required.

Physical requirements/ working conditions Travel: 10-30% – project dependent.