Principal Scientist Process

8562-Cilag AG Legal Entity; Schaffhausen; On-site; CHF 140,000 - 210,000; Full time

Job summary

Johnson & Johnson Innovative Medicine is seeking a Principal Scientist in Schaffhausen, Switzerland, to lead late-stage process development and technology transfer for biotherapeutics fill/finish. You will collaborate with MSAT, Quality, Regulatory and other functions to ensure compliant manufacturing processes and successful tech transfer across sites.

The role requires a Master/PhD in a technical field with 8+ years of biopharmaceutical experience, strong problem-solving, and fluency in

Qualifications

• Master degree or PhD in a technical field with at least 8 years in biopharmaceutical development/manufacturing.
• Demonstrated competency in biologics drug product development.
• Experience with biopharmaceutical process design, tech transfer and fill/finish operations.
• Knowledge of container-closure systems (vials, syringes, devices) is preferred.
• Ability to collaborate with cross-functional teams and influence outcomes.
• Excellent oral and written English and German.

Responsibilities

• Lead late-stage process development, tech transfer, process validation, and filing between sites.
• Author tech transfer documents, validation protocols/reports, and regulatory submissions.
• Support external/internal manufacturers in troubleshooting parenteral products.
• Serve as SME for fill/finish manufacturing during audits and regulatory reviews.
• Ensure processes comply with cGMP and align with J&J IM platforms.
• Provide feedback on technical performance to development teams.
• Drive transfer from lab to pilot to commercial scale.
• Help define scientific strategies for new product introductions.

Skills

Biologics

Process Development

Tech Transfer

CMC

Regulatory Submissions

Parenteral Fill/Finish

Analytical Thinking

Cross-functional Collaboration

Problem Solving

Autonomy

Education

Master Degree or PhD in Chemistry/Biochemical Engineering/Chemical Engineering/Pharmacy or related field

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at jnj.com. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function

Discovery & Pre-Clinical/Clinical Development

Job Sub Function

Biotherapeutics R&D

Job Category

Scientific/Technology

All Job Posting Locations

Schaffhausen, Switzerland

Job Description

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 leading 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 filing activities both to and between manufacturing sites (internal/external network) by providing Scientific support as well as technical project management.
• Responsible for timely authoring of tech transfer documents (e.g. tech transfer/process validation 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 J&J IM 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 molecule fill and finish.
• Demonstrated competency and experience in biologics drug product development within the biopharmaceutical industry is required.
• Consistently advances the boundaries of sci/tech knowledge, and proactively incorporates advancements aligning with practical business needs, regulations and compliance.
• Knowledge and applied experience of biopharmaceutical process design, technology transfer and drug product fill/finish operation.
• Experience with a variety of container-closure systems including vials, syringes and applicable delivery devices is preferred.
• Ability to collaborate and influence cross functional teams is a must.
• Excellent oral and written language skills in German and/or English.
• Motivated, self-starter able to work with a high level of autonomy with demonstrated problem-solving skills.
• Degree: Master Degree or PhD in a technical field (Chemistry, Biochemical Engineering, Chemical Engineering, Pharmacy or a related field) with at least 8 years of experience (including relevant academic research experience) in the biopharmaceutical development and manufacturing area.

Physical Requirements/ Working Conditions

Travel: 10-30% - project dependent.

“An internal pre-identified candidate for consideration has been identified. However, all applications will be considered”

Required Skills

• Preferred Skills: Analytical Reasoning, Biochemistry, Biotechnology, Chemistry, Manufacturing, and Control (CMC), Clinical Research and Regulations, Clinical Trial Designs, Collaboration, Data Synthesis, Drug Discovery Development, Molecular Diagnostics, Pharmacovigilance, Process Improvements, Productivity Planning, Program Management, Scientific Research, Tactical Planning, Technical Credibility

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at https://www.jnj.com/.

No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”!

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo. We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we in Switzerland are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.