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Job Function:

Discovery & Pre-Clinical/Clinical Development

Job Sub Function:

Biotherapeutics R&D

Job Category:

People Leader

All Job Posting Locations:

Schaffhausen, Switzerland

Job Description:

We are offering an outstanding opportunity for a

 

Scientific Senior Manager, Particulates Analytical Development (100%)

In this position, you will assume a leading role in the Particulates Analytical Development team in Schaffhausen. The team provides end-to-end support for large-molecule projects, including particle analytical procedures for release, characterization and stability testing of drug products,associated devices and combination products. You will apply scientific curiosity and analytical excellence to develop robust, phase-appropriate and compliant approaches in a GMP-regulated environment. A key responsibility will be translating scientific data and analytical strategies into clear technically rigorous content for global regulatory submissions.

You will provide scientific and operational leadership for investigation and complaint testing, site and QC laboratory support  and lifecycle support while influencing cross-functional decisions and advancing the team’s analytical capabilities. You will also oversee the AD BSL-2 laboratory and associated training activities.

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Responsibilities:

• Provide scientific and strategic leadership for particulate matter analytics

• Define phase-appropriate analytical strategies for visible and subvisible particulate matter and ensure alignment with product development needs, internal standards, and global health authority expectations

·         Lead and oversee method development, qualification, validation, transfer, investigation, and lifecycle activities for particulate matter assays, including planning, execution, documentation, and review

• Serve as SME for particulate analytics in cross-functional teams and provide scientifically sound recommendations for technical issues

• Author and critically review high-quality technical and regulatory documents, including analytical transfer reports, validation documentation, responses to health authority questions, and relevant sections of global regulatory submissions

• Interpret and integrate complex analytical data into clear scientific conclusions, risk assessments, and regulatory strategies

• Coordinate project deliverables, timelines, and interfaces with R&D, manufacturing sites, commercial quality control laboratories, and other external partners

·         Identify opportunities to strengthen particulate matter analytics capabilities, improve business processes, and evaluate emerging and innovative technologies to ensure the future-oriented development and sustainability of the analytical portfolio

• Support particle-counting analytical procedures for cell and gene therapy products

• Provide analytical support to QC laboratories, investigations, complaint testing, and site-support activities

• Oversee the AD BSL-2 laboratory, including responsibility for training and compliant laboratory operations

Profile:

For this position, we are looking for an experienced, scientifically curious, flexible, and team-oriented professional ideally with leadership experience with excellent communication and problem-solving skills, as well as the following qualifications:

• Master’s degree with at least 10 years of relevant industry experience, or PhD with a minimum of 7 years of relevant experience, in life science, engineering, analytical sciences, pharmaceutical sciences, or a related discipline

• Demonstrated experience in analytical method development, qualification, validation, or transfer for particle counting methods

• Demonstrated experience in authoring and reviewing technical content for regulatory submissions is required, including the ability to translate complex analytical data into clear, concise, and scientifically defensible regulatory narratives

• Strong record of technical writing and scientific presentation

• Excellent analytical and problem-solving skills, including the ability to identify gaps and root causes and develop practical, innovative solutions

• Ability to work independently, prioritize effectively, meet tight deadlines, and maintain a constructive attitude

• Demonstrated ability to lead complex, cross-functional teams, capability and commitment to developing a team-oriented, diverse, inclusive, and Credo-driven culture

• Scientific curiosity, a continuous-improvement mindset, and the determination to challenge the status quo responsibly
  
  “A pre-identified candidate for consideration has been identified. However, all applications will be considered”

 

 

Required Skills:

 

 

Preferred Skills:

Analytical Reasoning, Biochemistry, Chemistry, Manufacturing, and Control (CMC), Clinical Research and Regulations, Clinical Trial Designs, Developing Others, Drug Discovery Development, Inclusive Leadership, Leadership, Molecular Diagnostics, Pharmacovigilance, Process Improvements, Productivity Planning, Program Management, Quality Assurance (QA), Scientific Research, Tactical Planning, Team Management, Troubleshooting