Sr. Scientist AD

Johnson & Johnson Co.; Schaffhausen; On-site; CHF 110,000 - 160,000; Full time

Benefits offered by this job

Multinational team

Competitive salary

Career opportunities

Job summary

Johnson & Johnson in Schaffhausen, Switzerland, seeks a scientist to advance the CoE for particle counting in biotherapeutics within GMP environments. You will coordinate early and late phase programs, validate methods, and transfer to manufacturing and QC labs, drafting regulatory submissions and supporting marketed products.

You will contribute to the center of excellence, supervise SME activities, and collaborate across R&D and supply chain to ensure compliant, robust analytical approaches

Qualifications

• MS with 5+ years of life science or pharma development experience, or PhD with 2+ years.
• Strong analytics, project coordination and presentation skills.
• Experience with regulatory submissions and GMP environments is advantageous.
• Excellent English communication; German desirable.

Responsibilities

• Lead project coordination and method validation of particulate assays for biotherapeutics.
• Expand particle analytics portfolio for cell and gene therapy products.
• Coordinate validations and technology transfers per guidelines and health authority expectations.
• Collaborate with partners and represent SME in project meetings.
• Draft scientifically sound documents and compile data for regulatory submissions.
• Ensure end-to-end understanding of business processes and drive efficiency.
• Explore new technologies and perform scientific scouting.
• Work in a diverse, team-oriented environment with colleagues worldwide.

Skills

Analytical reasoning

Biochemistry

CMC

Project coordination

Regulatory writing

Communication skills

GMP knowledge

English proficiency

German desired

Education

M.S. in Life Sciences

PhD in Life Sciences

Tools

Analytical instruments

Job description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions 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: The Particulates team is a development laboratory within the global Janssen Research & Development organization and is embedded in the GMP environment of the Johnson & Johnson Innovative Medicine Supply Chain (IMSC). As part of Analytical Development, we provide end-to-end support in close collaboration with our R&D and IMSC partners. Our international, dynamic, and dedicated team supports biotherapeutic products across therapeutic areas including oncology, immunology, and neuroscience.

To strengthen our team we, are seeking a dedicated scientist to represent the team and coordinate early and late phase programs. In this position, you are responsible for further developing the center of excellence (CoE) for particle counting for biotherapeutic finished products, bridging and coordinating laboratory analytics. Your scientific dedication and agility to work in a GMP-regulated development environment are essential to ensure robust and compliant applications and approaches. After a thorough on-the-job training, you will have responsibility for project coordination, method validations and transfers to manufacturing sites and commercial quality control laboratories, drafting regulatory submissions and supporting marketed products.

Your Responsibilities:

• Assume a leading role in project coordination and method validation of particulate assays for biotherapeutic programs (protein and cell and gene therapy products) representing the Particulates team as subject matter expert (SME).
• Build on existing BSL-2 know-how and infrastructure to expand particle analytical portfolio for cell and gene therapy products
• Coordinate activities pertaining to particle method validations and transfers in compliance with internal guidances and health authority expectations
• Coordinate project-related tasks with our partners
• Represent the particulates team in project meetings as particle subject matter expert (SME)
• Writing scientifically sound technical documents
• Compiling data for registration dossier
• End-to-end understanding of business processes and ability to propose changes to strive for high efficiency
• Highly motivated to work on novel technologies and scouting for new technologies
• Work in a team-oriented environment and respect diversity and inclusion when interacting with partners and colleagues

Qualifications

For this position we are looking for a scientifically minded, flexible and team-oriented person with the following skills:

• Minimum requirement: M.S. with at least 5 years’ experience or PhD with at least 2 years’ experience in life science, material sciences, analytical development or pharmaceutical development
• Self-employed and entrepreneurial style
• Curiosity and drive to deep-dive into scientific questions
• Excellence in analytics, project coordination and presentation skills
• Experience in authoring and reviewing technical content for regulatory submissions advantageous
• Experience within the pharmaceutical or GMP-regulated industry preferred and knowledge of relevant GMP regulations for analytical laboratories
• Excellent communication skills in English (written and spoken), German desired

We are offering you a multifaceted opportunity in a dynamic, international environment with attractive terms and career opportunities as well as a good infrastructure!

Required Skills: Analytical Reasoning, Biochemistry, Chemistry, Manufacturing, and Control (CMC), Coaching, Consulting, Critical Thinking, Drug Discovery Development, Emerging Technologies, Molecular Diagnostics, Pharmacogenetics, Pharmacovigilance, Process Improvements, Quality Assurance (QA), Relationship Building, Research Documents, Scientific Research, Technologically Savvy