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**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:
**About Innovative Medicine **
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at https://www.jnj.com/innovative-medicine
We are searching for the best talent for Sr. Scientist Biotherapeutics RD to be in Schaffhausen
**Purpose: **
In this position you are responsible for analytical support of parenteral fill&finish lines and drug product R&D organizations for biotherapeutics (e.g. antibodies). You will be responsible for conducting analytical assay development and analytical support of fill-finish lines for release or characterization ensuring a high-quality, scientifically profound and timely delivery. You will also be responsible for implementation and maintenance of current instruments and novel technologies in a GMP-regulated environment including automation. You apply your open mindset to support the real-time release strategy and the implementation of new business opportunities as well you challenge the status quo with strong dedication and customer focus. You will conduct technical feasibilities (including DoE design, technology scouting, analytical testing) in close interaction with various stakeholders including regulatory affairs, quality, engineering and technical operations. As part of an international and multidisciplinary team, you will participate in strategic project meetings to provide project updates with scientific data for decisions and self-coordinate the planning of activities in close interaction with local management.
You will be responsible for:
- Be key in the implementation of new product introductions (NPIs) and new production process improvements in the clinical drug product manufacturing space.
- Plan, perform and document (GMP) analytical quality testing with various bioanalytical technologies
- Support the innovation and development of new (process) analytical technologies from proof-of-principle and support the pilot implementation in a manufacturing environment for large molecule modalities.
- Assess, develop and validate new analytical assays by conducting testing and review of analytical data under GMP.
- Connect and work in close contact with various stakeholders (including analytical and process development, quality and manufacturing)
- Understand the process and urgency of providing solutions to local and global customers.
- Deliver on the strategy for real-time release and integrated quality for large molecule drug product
- Work in a dynamic team-oriented environment and respect diversity and inclusion when interacting with colleagues and partners.
- Demonstrate a “right first time” culture and be open for new, innovative approaches
Qualifications / Requirements:
For this position we are looking for an analytically experienced, flexible and team-oriented person with excellent communication and negotiation skills as well as the following:
- PhD or M.S. with work experience in life or (bio-)engineering sciences, analytical or pharmaceutical sciences.
- Experienced in analytical development or engineering science. Significant emphasis on large molecule-based assays in a pharmaceutical or other GMP regulated industry is a plus.
- Understanding and experiences in a fill-finish process environment
- Self-starter and problem solver with determination to achieve common goals and questioning the status quo.
- Demonstrated ability to influence at all levels, to positively impact productivity and business results.
- A real team player with scientific curiosity and willingness to “go the extra mile”
- Proven track record to work independently across functions.
**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