Mission

Tasks and Responsabilities

• Day-to-day oversight of analytical activities performed at partnered CDMOs and CROs according to latest industry standards and regulatory guidance.
• Contribution to set up and development of in-house/outsorced analytical activities
• Definition of DS & DP specification according to applicable regulatory guidelines
• Prepare the plan for stability studies, reference standard, comparability studies
• Prepare and/or review technical documents including method development, method validation, transfer protocols and reports.
• Authoring and review of CMC regulatory analytical submissions documents
• Work closely with Drug Substance, Drug Product and Characterization Subject Matter Experts to develop analytical, characterization and comparability strategies
• Support defining/refining required processes for analytical/characterization activities
• Experience with analytical methods for GMP manufacturing
• Understanding of the detailed requirements for analytical validation and up to date with current trends
• Might include CMC leadership activities.

Education and Experience

• Master degree or Ph D in relevant scientific area or equivalent
• Experience with chromatographic and pharmacopeia methods for biologics
• Experience in establishing specifications
• Experience in preparing and reviewing relevant filing documentation for regulatory applications specially for early phase
• Experience with NBEs is preferred.

Competencies

• Knowledge of GMP, GLP, GCP, Regulatory processes, a plus.
• Strong collaboration skills and experience working with external partners
• Communication skills in English written and oral
• Analytical skills
• Prioritization and Organization skills

Values

• Care: we listen & empathize, we value diverse perspectives & backgrounds and we help each other succeed.
• Courage: we challenge the status quo, we take full ownership and we learn from our success & failures
• Innovation: we put the patient and customer at the center, we create novel solutions and we empower entrepreneurial mindsets.
• Simplicity: we act decisively and avoid over-analysis, we understand why before we act and we are agile & keep things simple.