Sr. Scientist AD

8562-Cilag AG Legal Entity; Schaffhausen; On-site; CHF 120,000 - 180,000; Full time

Job summary

Johnson & Johnson is seeking a scientist to lead coordination and validation of particulate assays for biotherapeutic programs in a GMP development setting. You will expand the particle analytics portfolio and collaborate with R&D and IMSC partners to ensure robust regulatory submissions.

The role requires an MS with 5+ years or PhD with 2+ years in life sciences or related fields, with strong analytical and communication skills in English (German desired).

Qualifications

• Minimum requirements include an MS with 5+ years or PhD with 2+ years in life science, materials science, analytical development, or pharmaceutical development.
• Experience in GMP-regulated environments and regulatory submissions is advantageous.
• Excellent English communication; German desired.

Responsibilities

• Lead project coordination and method validation of particulate assays for biotherapeutic programs (protein and cell/gene therapy).
• Develop and expand particle analysis capabilities; coordinate validations and transfers.
• Draft regulatory submissions and support marketed products; collaborate with R&D and manufacturing teams.

Skills

Analytical Reasoning

Biochemistry

Chemistry

Manufacturing and Control (CMC)

Coaching

Consulting

Critical Thinking

Drug Discovery Development

Emerging Technologies

Molecular Diagnostics

Pharmacovigilance

Process Improvements

Quality Assurance (QA)

Relationship Building

Research Documents

Scientific Research

Technologically Savvy

Education

MS or PhD in Life Sciences

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

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

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.

Required and Preferred 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.

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/.

Our Credo calls on us to respect the dignity of every individual and create an environment for all people to thrive. Throughout the recruitment process - from application through hiring - we are committed to providing reasonable accommodations/adjustments for qualified candidates with disabilities. If you need support at any stage of the recruitment process, please complete our candidate accommodation request form so we can assist you.