Scientific Senior Manager, Particulates Analytical Development

Johnson & Johnson Co.; Schaffhausen; On-site; CHF 180,000 - 210,000; Full time

Job summary

Johnson & Johnson in Schaffhausen seeks a Scientific Senior Manager to lead the Particulates Analytical Development team. You will drive end-to-end analytics for large‑molecule programs, shaping strategies for visible and subvisible particulates in a GMP setting.

You will translate complex data into regulatory submissions, oversee the BSL-2 AD lab, mentor staff, and partner with R&D, QC, and external collaborators to advance analytical capabilities across the portfolio.

Qualifications

• Master’s degree with 10+ years of industry experience in life sciences or related field.
• Option for PhD with 7+ years of relevant experience in analytical sciences or pharmaceutical sciences.
• Proven ability to translate analytic data into regulatory narratives and submissions.

Responsibilities

• Provide scientific and strategic leadership for particulate matter analytics across development programs.
• Lead method development, qualification, validation, transfer, and lifecycle activities for particulate assays.
• Author and review regulatory documents and responses for health authority submissions.
• Coordinate cross-functional work with R&D, manufacturing, and quality control teams.

Skills

Analytical method development

Regulatory submissions

Scientific writing

Cross-functional leadership

Education

Master’s degree with 10+ years in life sciences

PhD with 7+ years in related field

Tools

Particle counting methods

GMP knowledge

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

People Leader

All Job Posting Locations

Schaffhausen, Switzerland

Job Description

We are offering an outstanding opportunity for a

Scientific Senior Manager, Particulates Analytical Development (100%)

In this position, you will assume a leading role in the Particulates Analytical Development team in Schaffhausen. The team provides end-to-end support for large-molecule projects, including particle analytical procedures for release, characterization and stability testing of drug products,associated devices and combination products. You will apply scientific curiosity and analytical excellence to develop robust, phase-appropriate and compliant approaches in a GMP-regulated environment. A key responsibility will be translating scientific data and analytical strategies into clear technically rigorous content for global regulatory submissions. You will provide scientific and operational leadership for investigation and complaint testing, site and QC laboratory support and lifecycle support while influencing cross-functional decisions and advancing the team’s analytical capabilities. You will also oversee the AD BSL-2 laboratory and associated training activities.

Responsibilities

• Provide scientific and strategic leadership for particulate matter analytics
• Define phase-appropriate analytical strategies for visible and subvisible particulate matter and ensure alignment with product development needs, internal standards, and global health authority expectations
• Lead and oversee method development, qualification, validation, transfer, investigation, and lifecycle activities for particulate matter assays, including planning, execution, documentation, and review
• Serve as SME for particulate analytics in cross-functional teams and provide scientifically sound recommendations for technical issues
• Author and critically review high-quality technical and regulatory documents, including analytical transfer reports, validation documentation, responses to health authority questions, and relevant sections of global regulatory submissions
• Interpret and integrate complex analytical data into clear scientific conclusions, risk assessments, and regulatory strategies
• Coordinate project deliverables, timelines, and interfaces with R&D, manufacturing sites, commercial quality control laboratories, and other external partners
• Identify opportunities to strengthen particulate matter analytics capabilities, improve business processes, and evaluate emerging and innovative technologies to ensure the future-oriented development and sustainability of the analytical portfolio
• Support particle-counting analytical procedures for cell and gene therapy products
• Provide analytical support to QC laboratories, investigations, complaint testing, and site-support activities
• Oversee the AD BSL-2 laboratory, including responsibility for training and compliant laboratory operations

Profile

• Master’s degree with at least 10 years of relevant industry experience, or PhD with a minimum of 7 years of relevant experience, in life science, engineering, analytical sciences, pharmaceutical sciences, or a related discipline
• Demonstrated experience in analytical method development, qualification, validation, or transfer for particle counting methods
• Demonstrated experience in authoring and reviewing technical content for regulatory submissions is required, including the ability to translate complex analytical data into clear, concise, and scientifically defensible regulatory narratives
• Strong record of technical writing and scientific presentation
• Excellent analytical and problem-solving skills, including the ability to identify gaps and root causes and develop practical, innovative solutions
• Ability to work independently, prioritize effectively, meet tight deadlines, and maintain a constructive attitude
• Demonstrated ability to lead complex, cross-functional teams, capability and commitment to developing a team-oriented, diverse, inclusive, and Credo-driven culture
• Scientific curiosity, a continuous-improvement mindset, and the determination to challenge the status quo responsibly

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

Preferred Skills

• Analytical Reasoning
• Biochemistry
• Chemistry
• Manufacturing, and Control (CMC)
• Clinical Research and Regulations
• Clinical Trial Designs
• Developing Others
• Drug Discovery Development
• Inclusive Leadership
• Leadership
• Molecular Diagnostics
• Pharmacovigilance
• Process Improvements
• Productivity Planning
• Program Management
• Quality Assurance (QA)
• Scientific Research
• Tactical Planning
• Team Management
• Troubleshooting