Is a rapidly scaling, publicly listed, multimodal specialty CDMO built to serve the evolving needs of global biopharma innovators. The company integrates deep scientific expertise, complex product development capabilities, and robust regulatory execution to deliver differentiated, development-led solutions across biologics, drug–device combinations, complex injectables, and advanced oral technologies.

1. Build & Scale the Global R&D Engine

• Design and run a high-performing, multi-site R&D organization with strong governance, data integrity, and execution discipline.
• Establish operating models enabling future US/EU beachheads planned.
• Build technical bench strength: talent architecture, succession planning, capability depth across

modalities.

1. Scientific Rigor & Regulatory Credibility

• Set scientific standards, evidence thresholds, and development philosophy across programs.
• Ensure globally compliant, inspection-ready CMC packages from early development through commercialization.
• Embed risk-based development aligned with USFDA/EMA/ICH expectations.

1. Speed with Predictability (Right-First-Time)

• Own portfolio governance, stage-gate discipline, milestone reliability, and escalation mechanisms.
• Drive accelerated timelines without compromising science or triggering regulatory surprises.
• Institutionalize risk assessment, scenario planning, and robust tech transfer/commercial readiness.

1. Platformization & Repeatability (CMC Frameworks)

• Build reusable CMC platforms: standards, templates, playbooks, data models, and control strategies.
• Reduce reinvention and improve scalability through disciplined knowledge management.
• Strengthen QbD-driven lifecycle management and data-driven development.

1. Enterprise Leadership & External Scientific Interface

• Lead, mentor, and elevate senior scientific SMEs across sites and modalities.
• Serve as the senior scientific face in client engagements, technical diligence, audits, and critical escalations.
• Shape and defend technical strategy, guiding cross-functional decisions with authority and pragmatism.
• Engage CEO/Board/investors/strategic customers on scientific direction, capability building, and innovation roadmap.

• 15–20+ years in CMC R&D / Product & Process Development / Analytical Development / MSAT within CDMOs, global biopharma, or advanced development organizations.
• PhD strongly preferred (Master’s considered with exceptional scientific leadership credentials).
• Proven leadership of multi-site, multimodality R&D with strong global client interfaces.
• Track record delivering complex programs through development, tech transfer readiness, and commercialization.
• Strong command of QbD, risk assessment tools, lifecycle PQS concepts, regulatory guidelines, and data-driven control strategies.
• Ability to translate science into scalable platforms and repeatable development frameworks.
• Executive presence and scientific gravitas; credible at CEO/Board/CXO level.
• High ownership, enterprise mindset; balances strategy with operating discipline.
• Collaborative, decisive, and effective in fast-scaling, high-ambiguity environments.

A rare opportunity to architect the scientific backbone of a rapidly scaling, publicly listed, multimodal specialty CDMO and shape its global reputation as a trusted, development-led partner for complex, high-science programs.