Head of Scientific Excellence

Role Summary

Head of Scientific Excellence leads scientific expertise to accelerate technical modernization for product commercialization within the MSAT Recombinant Drug Substance platform, overseeing core platform activities such as product transfers, process monitoring, validation, material management, facility design, and CMC requirements.

Responsibilities

• Provide Scientific Expertise to advance CMC comparability strategy and approaches to enable health authority acceptance with evolving regulatory practices and guidance.
• Provide structured approach for modernization initiatives to drive platform excellence for key activities supporting new product introduction and 2nd generation products.
• Material Sciences leadership to drive improvements in material quality and testing standardization (L&E). Leverage supplier partnerships for accelerating technical innovation and efficiency gains for technical project provision.
• Provide oversight on strategies and approaches for cell bank management including testing, qualification and supply security.
• Drive and execute the strategic direction of Environmental Sustainability by Design initiatives, fostering a culture of environmental sustainability and innovation in pharmaceutical development.

Qualifications

• PhD/Master’s degree in Life Sciences and/or Chemical Engineering, Biotechnology, Biology, Biochemistry, Pharmacy, or related.
• 10+ years of broad and long-term experience in biotech/pharmaceutical industry (R&D and/or MSAT) with manufacturing cGMP considerations and global CMC projects.
• 5+ years of experience with CMC regulatory guidance specific to process/analytical comparability and health authority submissions.
• 5+ years of leadership experience leading cross-functional teams in a matrix organization; global exposure and stakeholder management experience.
• Experience with material management including evaluation, change control and testing.
• Specialist knowledge in material sciences, Single-Use technologies (SUT), technical process or analytical platform evaluation.
• Preferred experience with cell bank qualification and management.
• Strong scientific background in biological process development and/or product analytics; good understanding of cGMP requirements and facility operations; high experience in change management and transversal collaboration.

Skills

• Proven ability to lead cross-functional teams in a matrix organization; global exposure and stakeholder management experience.
• Excellent communication and interpersonal skills; ability to lead networks and teams of experts.
• Strategic thinking with pragmatic focus on priorities; results orientation from concept to execution.
• Autonomy, comfort with ambiguity, high adaptability.
• People development; ability to set ambitious goals and align priorities across the organization.
• Relationship and influence skills to manage ambiguity and partner without solid reporting lines; ability to influence outside MSAT including regulatory, development, and finance.
• Empathy-based leadership, ability to empower and build strong networks; commitment to patient and product quality.
• Issue resolution and decision-making capabilities.

Education

• PhD or Master’s degree in Life Sciences, Chemical Engineering, Biotechnology, Biology, Biochemistry, Pharmacy, or related.