Serve as a strategic partner with the Tech Ops and CMC leadership to define regulatory strategies.
Bring hands-on experience to author regulatory submissions within US and Ex-US, coaching and guiding AD/QC staff to author reg submissions.
Work with Tech ops senior leadership to define, develop and execute CGO’s post commercial pathway.
Build sustainable and appropriate organization structure to support CGO future growth from late stage company to a commercial and growing company.
Define and execute the global analytical development strategy across all stages of development, from late-stage clinical through commercial lifecycle management.
Ensure analytical methods are scientifically sound, phase-appropriate, robust, and aligned with regulatory expectations.
Oversee method development, qualification, validation, transfer, and lifecycle management for drug substance and drug product.
Lead and scale Quality Control operations, including in-house and external QC testing activities.
Ensure QC systems meet GMP requirements and remain inspection-ready.
Support regulatory submissions and serve as an analytical SME for health authority interactions.
Build, lead, and mentor a high-performing Analytical Development and Quality Control organization.
Manage external laboratories, CROs, CDMOs, and testing partners.
Collaborate cross-functionally to support tech transfer and commercialization readiness.

PhD or MS in Analytical Chemistry, Pharmaceutical Sciences, Chemistry, Biochemistry, or related discipline.
15+ years of experience in analytical development and/or quality control in biotech or pharma.
Experience supporting late-stage clinical programs, BLA submissions, and commercial readiness.
Deep knowledge of GMP, ICH guidelines, and global regulatory expectations.
Proven experience leading and scaling analytical and QC organizations

Vice President, Analytical Development, Quality Control

Key skills