Johnson & Johnson, through its operating companies, is the world's most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices and diagnostics markets. We strive to provide scientifically sound, high quality products and services to help heal, cure disease and improve the quality of life.
Cilag AG is a successful international development and manufacturing facility in the pharmaceutical sector of Johnson & Johnson, located in Schaffhausen, Switzerland. At our Schaffhausen site, 130 people work for the global Janssen Research & Development organization developing innovative treatments that improve the health and lifestyles of people worldwide. Janssen Research & Development Schaffhausen is recruiting for a
Principal Scientist (f/w/d) - Ref.: 2005839695W
The successful candidate will work in the Biotherapeutics Drug Product Development (DPD) department. The incumbent will scientifically lead trouble shooting and root cause investigations with scope of End to End manufacturing processes and formulation of Biotherapeutics.
YOUR responsibilities & YOUR impact:
Serves as a technical point of contact for Biotherapeutics issues in development or in commercial operations
Identifies and analyzes high-impact, complex and cross-departmental scientific/technical issues and gaps.
Partners with functional groups in Development and Supply Chain, especially with Analytical Development, Drug Substance Manufacturing and Material Science to ensure processes are consistent to accepted Janssen platforms and are in compliance with the submitted CMC dossiers and the general cGMP regulations.
Contributes to defining scientific strategy across programs/projects by developing ideas and new approaches covering continuous scientific and technology advancement, benchmarking, and evolving strategy with respect to regulatory and healthcare expectations and strategy in relation to sourcing and geographic footprint.
Scientific direction and mentorship to scientists and engineers for products in development. Enables scientists to nurture new scientific insights; and provide development opportunities working under indirect supervision with a high level of autonomy.
Prepare documents for regulatory filings and internal company use
We would love to hear from YOU, if you have:
PhD with 6 – 12 years industry experience or a MS with at least 10 years industry experience in Biotechnology, Bioengineering or Pharmaceutical Sciences or related Scientific discipline is required
Experience and Skills:
Track record of successfully concluded root cause investigations in Biotherapeutics manufacturing preferably including how particles are generated during various formulation development and process operations
Experience maintaining high quality documentation, analyze and accurately interpret data, and prepare scientific reports
Knowledge and experience of biopharmaceutical formulation, process design and fill/finish operations
Knowledge of how excipients interact to prevent and/or cause particle formation
Experience with studying particle formation in various delivery systems including but not limited to controlled release, nanotechnology, encapsulation, long acting injectables
Strong physio-chemical understanding of particle formation in therapeutic proteins including cell and gene therapies
Sound protein analytical knowledge and experience with a variety of standard protein analytical methods
Ability to conduct multiple scientific projects in an organized and productive manner.
High sense of responsibility regarding scientific and professional activities. Excellent oral and written language skills in German and English.
This is what awaits YOU at J&J:
An opportunity to be part of a global market leader.
A dynamic and inspiring working environment.
Many opportunities to work on challenging projects and assignments.
Possibilities for further personal as well as professional development.
Many employees benefits.
The position may require approx. 15% time for business travelling
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.