Sr. Scientist Proteins AD

Johnson & Johnson; Schweiz; On-site; CHF 120,000 - 160,000; Full time

Job summary

Johnson & Johnson in Schaffhausen, Switzerland, seeks a Senior Scientist to lead CCIT and related analytical development programs in a GMP environment. You will coordinate method development, validation, and transfer, support investigations, and contribute to regulatory submissions, while collaborating with international partners.

The role requires a Master’s or PhD with multiple years in life sciences or analytical development, and strong written/spoken English, with German desirable.

Qualifications

• We are seeking a scientifically minded professional with hands-on experience in CCIT, SBIT, RSF, and analytical method development.
• Experience in GMP environments and regulatory documentation is required.
• Excellent English communication; German skills are desirable.

Responsibilities

• Lead projects for CCIT, SBIT, and related assays across container closure systems.
• Coordinate method development, validation, and transfer activities.
• Provide timely scientific support for investigations and regulatory deliverables.
• Align project plans with internal and external partners.
• Represent the CCI team in project meetings as SME.
• Author study protocols, reports, and validation documentation.
• Interpret and communicate analytical data for decisions.
• Develop end-to-end understanding of business processes and propose improvements.
• Evaluate emerging technologies and translate to lab capabilities.
• Contribute to an inclusive, team-oriented environment.

Skills

Analytical Development

Coaching

Critical Thinking

GMP Compliance

Project Coordination

Regulatory Documentation

Scientific Writing

Head Space Analysis

Helium Leak Detection

CCIT at Frozen conditions

Residual Seal Force Testing

Stakeholder Communication

CMC

Investigation

Emerging Technologies

Process Improvement

Quality Assurance

Relationship Building

Technologically Savvy

Education

Master’s degree

PhD

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:

Job Description:

The Container Closure Integrity (CCI) team is a development laboratory within the global Research & Development organization and operates in the GMP environment of Johnson & Johnson Innovative Medicine Supply Chain (IMSC). As part of Analytical Development, we provide end-to-end support for biologics and advanced therapy products, including antibodies, cell and gene therapies, and antibody-drug conjugates, across therapeutic areas including oncology, immunology, and neuroscience. We work closely with R&D and IMSC partners in an international, dynamic, and collaborative environment.

To strengthen our team, we are seeking a Senior Scientist to lead projects for early- and late-phase development programs and commercial products. You will help advance our center of excellence (CoE) for container closure integrity testing (CCIT) of primary containers, sterile barrier integrity testing (SBIT) of devices and residual seal force testing (RSF), expand laboratory capabilities, and deliver robust, compliant analytical strategies and analytical procedures in a GMP-regulated development environment. Following comprehensive on-the-job training, you will coordinate projects, lead method development, validation, and transfer activities, support investigations, contribute to regulatory submissions, and provide analytical support for marketed products.

Your Responsibilities:

o Assume a leading role in project coordination, development and validation of CCIT, SBIT and related assays for a variety of container closure systems (CCS) and devices for cell and gene therapy, antibody, and antibody-drug conjugate programs, representing the CCI team across J&J Innovative Medicine.

o Coordinate method development, validation, and transfer activities in accordance with internal guidance and health authority expectations.

o Provide timely scientific support for investigations and other high-priority stakeholder requests with short turnaround times.

o Align project plans, deliverables, timelines, and risks with internal and external partners.

o Represent the CCI team in project meetings as a subject matter expert.

o Author scientifically sound technical documents, including study and validation protocols, reports.

o Compile, interpret, and communicate analytical data to support project decisions, investigations, and regulatory deliverables.

o Develop an end-to-end understanding of business processes and propose improvements that increase quality and efficiency.

o Evaluate emerging technologies and translate promising approaches into fit-for-purpose laboratory capabilities.

o Contribute to an inclusive, team-oriented environment and collaborate respectfully with partners and colleagues.

Qualifications

We are looking for a scientifically minded, flexible, and collaborative professional with the following qualifications:

o Independent, accountable, and entrepreneurial working style.

o Scientific curiosity and the ability to investigate complex questions in depth.

o Strong analytical reasoning, project coordination, communication, and presentation skills.

o Experience with container closure systems, such as vials, prefilled syringes or cartridges, bags, or devices such as needle-based injection systems and on-body delivery systems are advantageous.

o Experience in the pharmaceutical industry or another GMP-regulated environment, with knowledge of GMP requirements for analytical laboratories, is preferred.

o Excellent written and spoken English; German language skills are desirable.

o Master’s degree with at least five years of relevant experience, or PhD with at least two years of relevant experience, in life sciences, materials science, analytical development, pharmaceutical development, or a related field.

We offer a varied and impactful role in a dynamic, international environment, with strong infrastructure and opportunities for professional growth.

Required Skills:

Preferred Skills:

Analytical Development, Coaching, Critical Thinking, GMP Compliance, Project Coordination, Regulatory Documentation, Scientific Writing, Head Space Analysis, Helium Leak Detection, CCIT at Frozen conditions, Residual Seal Force Testing, Stakeholder Communication, CMC, Investigation, Emerging Technologies, Process Improvement, Quality Assurance, Relationship Building, Technologically Savvy

Job Function:

Discovery & Pre-Clinical/Clinical Development

Job Sub Function:

DPDS, TDS Proteins AD

Job Category:

Scientific/Technology

Primary Job Posting Location:

Schaffhausen, Switzerland

Additional Job Posting Locations:

Legal Entity Name:

8562-Cilag AG Legal Entity

Pay Grade:

26

Required Skills:

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