Scientific Senior Manager, Particulates Analytical Development

JRNLClub; Schaffhausen; Vor Ort; CHF 180.000 - 240.000; Vollzeit

Zusammenfassung

Johnson & Johnson in Schaffhausen seeks a Scientific Senior Manager for Particulates Analytical Development (100%). You will lead the Particulates Analytical Development team overseeing particle analytics for release, characterization and stability testing in a GMP setting.

You translate complex data into regulatory content for global submissions, provide leadership for investigations and lifecycle support, and manage the AD BSL-2 laboratory ensuring compliant operations in a fast-paced

Qualifikationen

• Proven experience in analytical method development, qualification, validation or transfer for particle counting methods.
• Experience authoring and reviewing regulatory submissions and translating complex analytical data into regulatory narratives.
• Strong technical writing and presentation skills with the ability to lead cross-functional teams.

Aufgaben

• Provide scientific and strategic leadership for particulate matter analytics.
• Lead method development, qualification, validation, transfer, investigation, and lifecycle activities for particulate matter assays.
• Serve as SME for particulate analytics in cross-functional teams and provide scientifically sound recommendations for technical issues.
• Author and review regulatory documents, transfer reports, validation documentation, and responses to health authority questions.
• Coordinate project deliverables and interfaces with R&D, manufacturing, QC labs, and external partners.
• Identify opportunities to strengthen analytics capabilities and evaluate emerging technologies.
• Oversee the AD BSL-2 laboratory and training activities.

Kenntnisse

Analytical reasoning

Biochemistry

Chemistry

Manufacturing and Control

Clinical Research and Regulations

Regulatory submissions

Team leadership

Ausbildung

Master's degree + 10+ years or PhD + 7+ years

Jobbeschreibung

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 analyticsDefine 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 issuesAuthor 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 submissionsInterpret and integrate complex analytical data into clear scientific conclusions, risk assessments, and regulatory strategiesCoordinate 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 productsProvide analytical support to QC laboratories, investigations, complaint testing, and site-support activitiesOversee the AD BSL-2 laboratory, including responsibility for training and compliant laboratory operations

Profile

For this position, we are looking for an experienced, scientifically curious, flexible, and team-oriented professional ideally with leadership experience with excellent communication and problem-solving skills, as well as the following qualifications: 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 disciplineDemonstrated experience in analytical method development, qualification, validation, or transfer for particle counting methodsDemonstrated 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 narrativesStrong record of technical writing and scientific presentationExcellent analytical and problem-solving skills, including the ability to identify gaps and root causes and develop practical, innovative solutionsAbility to work independently, prioritize effectively, meet tight deadlines, and maintain a constructive attitudeDemonstrated ability to lead complex, cross-functional teams, capability and commitment to developing a team-oriented, diverse, inclusive, and Credo-driven cultureScientific curiosity, a continuous-improvement mindset, and the determination to challenge the status quo responsibly

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