Analytical Project Lead

About us

As a leading Contract Development and Manufacturing Organization (CDMO), Ardena partners with pharmaceutical companies of all sizes—from emerging biotech to global industry leaders—united by the mission to help biopharma innovators navigate drug development with precision, quality, and speed, bringing their molecules from discovery to the clinic and market. Our fully integrated services span drug substance and drug product development, manufacturing, nanomedicine, clinical logistics, bioanalytical services, state research, fill & finish, and CMC regulatory support.

With a rapidly growing international footprint, Ardena is home to over 750 professionals across six strategic locations—Belgium (Ghent), the Netherlands (Oss and Assen), Sweden (Södertälje), Spain (Pamplona), and Somerset, New Jersey (the US). Our open and transparent culture is built on collaboration, ownership, and innovation, guided by our We CARE values. We foster a communicative environment where mutual respect, accountability, and excellence empower our team.

We are looking for skilled and motivated professionals eager to grow their careers in an exciting and fast-paced environment. Whether you're an experienced expert or just starting out, Ardena provides a dynamic workplace where you can contribute to meaningful drug development projects, expand your knowledge, and be part of a global team committed to making a difference. As an international organization, we help you navigate a career path that expands your possibilities beyond borders, opening doors to personal and professional growth without limits. Your potential to grow is limitless with us.

If you are ready to take on new opportunities, work alongside industry experts, and contribute to the future of medicine, Ardena is the place for you.

For the Ardena Business Unit based in Södertälje, we are looking for a Senior Analytical Chemist for the role of Analytical Project Lead in Analytical Development as a permanent position.

WHAT YOU WILL WORK ON

Analytical Project Lead in the Analytical Science (AS) department (Analytical Development and Quality Control, ADQC).

YOUR ROLE

As an Analytical Project Lead in the AS department, you will play a pivotal role in coordinating early and late clinical phase projects, ensuring execution in compliance with Ardena's manufacturing capabilities and regulatory standards. You will serve as the primary point of contact for customer interactions regarding analytical development and quality control progress and lead daily team meetings to align priorities and drive project momentum. You will work closely with other stakeholders (Project Management, Quality Assurance, Process Development and Manufacturing teams) to deliver high-quality solutions that align with Ardena's mission.

WHAT YOU WILL WORK ON

YOUR KEY RESPONSIBILITIES

• You will be working as a senior member in the AS department with a focus on project coordination, documentation work and reviews.
• You will coordinate early to late-phase clinical projects and ensure alignment with internal and external stakeholders.
• You will lead daily team meetings in the AD team and deputise the team manager when required.
• You will maintain an overview of all ongoing projects within the AD team and be involved in planning and tracking progress across different tasks.
• You will write and review validation protocols, data, and reports.
• You will write and review specifications (Justification of Specifications and Release Specifications).
• You will be involved in the review of analytical method transfer to the Quality Control team.
• You will be responsible for maintaining status of compendial/pharmacopeia methods and ensure updates in line with ICH guidelines.
• You will be a point of contact for customers regarding analytical topics.
• You will be involved in quality control activities such as reviewing of documentation related to release testing (specifications, CoA's).
• You will be involved in laboratory design, analytical method transfers, and instrument re-location as the team will move to our other Södertälje site.

YOUR PROFILE

• You have a university degree in Analytical Chemistry, Chemical Engineering, Biotechnology or similar.
• You have at least 2 years of experience from working with analytical chemistry.
• You have a minimum of years of experience from work with chromatography.
• You have at least 2 years experience from working in a cGMP/GLP environment.
• You have experience from reviewing of  data from analytical development and quality control work.
• Experience with Chromeleon Chromatography Data Software is a merit.
• Experience from work with late stage clinicla projects is a merit.
• Previous experience from reviewing method validation and method development work is a merit.
• You feel comfortable in a dynamic and changing environment.
• You have strong analytical and problem-solving ability.
• You like to learn and develop yourself.
• You are flexible, a problem solver and a team player.
• You have an analytical mindset, and you can handle multiple projects at the same time.
• You have good communication skills and are fluent in English (written as well as spoken).

WHAT WE OFFER

A true learning environment where you will have the ability to grow your skills

An attractive wellness allowance

Flexible working hours

A dynamic, international work environment with nice colleagues and caring culture

A chance to contribute to groundbreaking drug development projects that make a real impact

Please submit your application no later than 25 Nov2025. Selection takes place on an ongoing basis and the position may be filled before the application period has expired.

Ready to start your career path with Ardena? Click the application button and join us in shaping the future of drug development

Only candidates eligible to work in the EU will be considered for the position. Unfortunately, given the high volume of applications we receive for our vacancies, these professionals (not entitled to work in the European Union) will not be given a status update. Agency calls will not be appreciated.