Senior Analytical Development Lead — Global CMC Strategy

IBSA Nordic ApS; Holbæk; On-site; DKK 900,000 - 1,300,000; Full time

Job summary

Pharmacosmos seeks a Principal Analytical Development Chemist to lead analytical development across CMC programs, from early development through commercialization and lifecycle activities. You will drive method development, qualification, transfer, and impurity profiling to establish robust specifications and control strategies.

Working with Drug Substance/Product Leads, Regulatory Affairs, QA/QC, and CRO/CDMO partners, you will ensure regulatory readiness, quality execution, and timely delivery

Qualifications

• MSc or PhD in Analytical Chemistry, Pharmaceutical Sciences, Chemistry, or a related scientific discipline.
• 10+ years of pharmaceutical industry experience in analytical development.
• Strong track record in analytical development across drug substance and drug product.

Responsibilities

• Lead analytical development across CMC programs from early development through commercialization and lifecycle activities.
• Drive analytical characterization, method development, qualification, transfer, and impurity profiling.
• Establish specification setting, stability programs, and analyte control strategies to support regulatory submissions and manufacturing.
• Mentor colleagues and collaborate with cross-functional teams including Regulatory Affairs, QA, QC, and CRO/CDMO partners.

Skills

Analytical chemistry

Pharmaceutical sciences

Method development

Regulatory readiness

Project management

Education

MSc in Analytical Chemistry

PhD in Chemistry/Pharmaceutical Sciences

Job description

Pharmacosmos seeks a Principal Analytical Development Chemist to lead analytical development across CMC programs, from early development through commercialization and lifecycle activities. You will drive method development, qualification, transfer, and impurity profiling to establish robust specifications and control strategies.

Working with Drug Substance/Product Leads, Regulatory Affairs, QA/QC, and CRO/CDMO partners, you will ensure regulatory readiness, quality execution, and timely delivery