Ardena is building a global leader in precision medicine development, supporting the creation of new, innovative, and complex molecules. As an integrated specialist CDMO and CRO, Ardena guides pharmaceutical and biotechnology partners through the complexities of bringing new treatments to market with precision, quality, and speed. Ardena employs more than 750 professionals across Europe and the United States and provides integrated services across drug substance and drug product development, manufacturing, bioanalytical services, clinical logistics, fill and finish, and CMC regulatory support.
For the Ardena Bioanalysis Business Unit based in Assen, The Netherlands, we are looking for an experienced and inspiring Associate Director Operations (Immunochemistry).
In this pivotal role, you combine strategic leadership with deep bioanalytical expertise to steer, optimize, and future‑proof our laboratory operations. Ardena Bioanalysis is a fast‑growing, GLP/GCP‑compliant organization delivering innovative bioanalytical solutions to global pharmaceutical partners. Our work supports drug development from early discovery through phase IV clinical studies. Our mission is to provide precise quantitative and qualitative analyses of drugs and biomarkers in biological matrices using cutting‑edge techniques, including LC‑MS/MS, ligand‑binding assays (ELISA), qPCR, and flow cytometry. Our growing team of bioanalytical scientists brings expertise across diverse fields, covering small molecules, peptides, cells, and proteins, such as antibodies, antibody‑drug conjugates, oligonucleotides, and nanoparticles. You will join a dynamic environment where quality, collaboration, and continuous improvement are at the heart of what we do.
Your RoleAs Associate Director Operations, you are responsible for day‑to‑day oversight of operational activities within the immunochemistry department. You translate site and divisional strategies into measurable objectives, manage planning, capacity, and quality, and create the conditions for efficient laboratory workflows. You act as a strategic partner to senior leadership, provide guidance to team leaders and scientific staff, and serve as an operational contact for clients.
Your Key Responsibilities- Provide daily leadership to the department and ensure robust planning, prioritization, and execution of bioanalytical studies.
- Optimize project management processes and laboratory workflows.
- Oversee resource allocation (personnel, equipment, materials) and proactively resolve bottlenecks.
- Implement continuous improvement initiatives to enhance productivity and reduce operational costs.
- Ensure full compliance with GLP/GCP, FDA, EMA, and other regulatory guidelines; maintain audit‑/inspection‑readiness.
- Support QA activities including deviations, CAPAs, audit findings, and client feedback.
- Lead, mentor, and develop project managers, team managers, and scientific/technical staff.
- Contribute to business planning, operational strategy, and identification of technological improvements.
- Act as a key operational contact for clients and provide input for new project proposals.
- MSc/PhD in Analytical Chemistry, Biochemistry, Pharmacology, Life Sciences, or a related field.
- 8–12+ years of bioanalytical experience in a GLP/GCP environment.
- At least 3–5 years of leadership experience in a regulated laboratory setting.
- In‑depth understanding of immunoassay/biomarker platforms, including validation and transfer.
- Proven track record in leading laboratory teams and managing complex study portfolios.
- Strong background in operational excellence, resource management, and audit readiness.
- Fluency in Dutch and English.
- Experience in a CRO environment and clinical bioanalysis (PK/PD, ADA/NAb).
- Lean/Six Sigma certification (Green/Black Belt) or project management certification (PMP/Prince2).
- Hands‑on experience with LIMS/ELN platforms and data integrity requirements.
Ardena’s CARE competency framework applies to all roles: Communicative – Accountable – Reliable – Excellent.
Role‑specific competencies include:
- Leadership and supervision
- Planning and organizing
- Customer focus
- Quality orientation
- Ethical and transparent behavior
- Adaptability and change resilience
- Salary range: €6,500 to €7,300 gross per month (based on a 40‑hour workweek, depending on experience).
- A true learning environment where you can grow your skills.
- A rapidly developing and expanding company with an interesting portfolio of services, products, and clients.
- A dynamic working environment with friendly and enthusiastic colleagues.
- A company culture with open communication, where employee well‑being is highly valued.
- An attractive remuneration package.
- Flexible working hours.
Ready to apply? Please click on the application button.
Only candidates eligible to work in the EU will be considered for the position. Given the volume of applications we receive, professionals not eligible to work in the European Union will not receive a status update. Agency calls will not be appreciated.
#J-18808-Ljbffr€6500 - €7300 monthly