Sr. Scientist Biologics AD
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Job Location:
Schaffhausen - Switzerland
Monthly Salary:
Not Disclosed
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at .
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 DevelopmentJob Sub Function:
Biotherapeutics R&DJob Category:
Scientific/TechnologyAll Job Posting Locations:
Schaffhausen SwitzerlandJob Description:
The Particulates and Container Closure Integrity (PCCI) team is a development lab within the global Janssen Research & Development organization 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 working closely with our R&D partners and IMSC in an international dynamic and dedicated team responsible for biotherapeutic products across numerous therapeutic areas such as oncology immunology and neuroscience.
To strengthen our team we are seeking a dedicated senior scientist to represent the team and coordinate early and late phase and commercial this position you are responsible for further developing the center of excellence (CoE) for container closure integrity testing (CCIT) for products in the cell and gene therapy antibody and antibody drug conjugate space building up growing and coordinating laboratory analytics for CCI testing. 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 validation of CCIT assays for cell and gene therapy antibody and antibody drug conjugate programs representing the PCCI team and supporting our partner organizations.
Build on existing biosafety know-how and infrastructure to expand CCIT analytical portfolio for cell and gene therapy products
Coordinate activities pertaining to PCCI CCIT method development validations and transfers in compliance with internal guidances and health authority expectations
Coordinate all project-related tasks with our partners
Represent the PCCI team in project meetings as CCIT subject matter expert
Writing scientifically sound technical documents e.g. study/validation protocols and reports
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:
Self-employed and entrepreneurial style
Curiosity and drive to deep-dive into scientific questions
Excellence in analytics project coordination and presentation skills
Background in CCIT and cell and gene therapy antibody and antibody drug conjugate analytics 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
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
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:
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 SavvyRequired Experience:
Senior IC
Key Skills
- Laboratory Experience
- Immunoassays
- Machine Learning
- Biochemistry
- Assays
- Research Experience
- Spectroscopy
- Research & Development
- cGMP
- Cell Culture
- Molecular Biology
- Data Analysis Skills
About Company
About Johnson & Johnson A t Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s larges ... View more
