Responsibilities:
- Responsible for all analytical sciences activities for Synthetic/Small Molecules and Solid Oral Dosage Forms at the Cambridge Crossing site
- Develop and apply advanced analytical strategies for First in Class/Best in Class R&D programs
- Design, develop and apply analytical technologies
- Drive analytical sciences innovation aligned with the labβs digitalization and automation road map
- Develop people and the organization in line with Take The Lead strategy
Key Activities:
Strategic
- Participate in the strategic evolution of Analytical Sciences aligned with the Synthetics Platform and Global CMC Development strategy and project needs
- Interface with key partners to deliver pipeline/projects
- Promote a βone-teamβ culture across DS, DP, Analytics, and clinical dossier development
- Lead Digital Transformation
- Represent the company in internal/external forums
Scientific
- Lead transversely the analytical sciences team
- Drive analytics for process chemistry support, pre-formulation, control strategy, and stability studies across intermediates, starting materials, DS, and DP
- Upgrade analytical technologies to drive innovation and generate IP
- Scan external environment for opportunities and relevant collaborations
Operational
- Allocate resources to deliver projects by priority
- Provide transversal analytical support to other CMC Synthetics functions
- Propose analytical training and new technologies
- Oversee outsourced activities; decide what to internalize
- Review and approve scientific documents
People
- Manage the Analytical Sciences team; coach, provide feedback, attract/hire/retain/motivate talent
Qualifications:
- BS (14+ yrs) OR MS (12+ yrs) OR PhD (10+ yrs) in Analytical Chemistry or related field in pharmaceutical industry
- 3+ years people management/leadership
- Strong regulatory knowledge (ICH, EMA/FDA, international standards)
- Proven clinical trial documentation and regulatory dossier submission experience
- Strong R&D analytical sciences track record; advanced academia/industry network
- GMP/ICH requirements and pharmacopoeia knowledge; CTD submission experience
- Solid CMC understanding (chemistry, physical quality, formulations); technical/organizational skills in matrix environments
- English
Benefits:
- Health and wellbeing benefits; high-quality healthcare and prevention/wellness programs; at least 14 weeksβ gender-neutral parental leave.