Principal Analytical Development Chemist

IBSA Nordic

Holbæk

On-site

DKK 900,000 - 1,300,000

Full time

8 days ago

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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

Principal Analytical Development Chemist
About the job Principal Analytical Development Chemist

Join Pharmacosmos in a newly established role and take a leading scientific role in shaping the analytical development capabilities.

Lead complex Analytical Development across a growing development pipeline
As Principal Analytical Development Chemist at Pharmacosmos, you will serve as the Analytical Lead across CMC development programs, driving analytical development, characterization, control strategies, and regulatory readiness from early-stage development through commercialization to lifecycle activities.

In this high impact role, you will be responsible for driving analytical development and ensuring that robust analytical methods, specifications, stability strategies, and control frameworks are established to support successful product development, regulatory submissions, and commercial manufacturing. You will apply your scientific expertise to complex analytical challenges, including product characterization, impurity profiling, method development, method qualification, validation strategy, comparability assessments, and technical investigations, helping to de-risk development programs and accelerate progress.

Working closely with Drug Substance Leads, Drug Product Leads, Regulatory Affairs, Quality Assurance, Quality Control, and external development partners, you will provide strategic guidance and scientific leadership across the organization. You will oversee analytical activities performed both internally and through CROs, CDMOs, and specialist laboratories, ensuring high-quality execution, sound scientific decision-making, and timely delivery of project objectives.

Beyond supporting individual projects, you will contribute to strengthening Pharmacosmos' analytical capabilities by advancing laboratory technologies, scientific best practices, and knowledge sharing across teams. As a trusted technical expert, you will mentor colleagues, influence key decisions, and help build a culture of scientific excellence, continuous improvement, and cross-functional collaboration.

Highly skilled Analytical Development Chemist with strong project management capabilities
We are seeking a highly qualified candidate with an MSc or PhD in Analytical Chemistry, Pharmaceutical Sciences, Chemistry, or a related scientific discipline. You bring extensive experience from the pharmaceutical industry, typically gained over 10 years or more, and possess a strong track record within analytical development ideally across both drug substance and drug product development. You have in-depth experience with analytical characterization, method development, qualification, and transfer, as well as specification setting, stability programs, impurity characterization, and analytical control strategies. Experience working with CROs, CDMOs, external laboratories, and cross-functional CMC teams is essential, together with a solid understanding of regulatory requirements and CMC documentation. You are an established scientific leader who can independently drive complex analytical activities and influence decision-making through technical expertise and sound scientific judgment.

You are a scientifically driven and highly analytical professional who thrives in a dynamic and collaborative environment. You combine deep technical expertise with a pragmatic and solution-oriented mindset and are motivated by solving complex challenges and advancing pharmaceutical development programs. You work independently, take ownership of your responsibilities, and communicate complex scientific topics with clarity and credibility. Through strong collaboration and stakeholder engagement, you create alignment across functions and external partners while maintaining focus on quality, timelines, and business objectives. You are structured, proactive, and resilient, with a strong sense of integrity and accountability, and you enjoy sharing knowledge and contributing to a culture of scientific excellence and continuous improvement. Finally, you are fluent in English, both written and verbal.

Play a crucial role in an exciting international growth journey

Pharmacosmos
Pharmacosmos A/S is a global leader in carbohydrate chemistry and innovative treatments for iron deficiency and iron deficiency anaemia. Building on our foundational expertise in carbohydrate chemistry and cell cycle biology, we develop innovative treatments for unmet patient needs, with a focus on iron metabolism and blood-related disorders. Founded in 1965 and headquartered in Denmark, our team is made up of more than 650 specialists across the UK, Ireland, the Nordics, Germany, Canada, and the USA. Learn more about Pharmacosmos at www.pharmacosmos.com .

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