Stellenbeschreibung
We are excited to announce the job opening for an Associate Director (m/f/d) Analytical Transfer Lead to lead and execute analytical transfer activities on Monoclonal Antibodies from R&D to an internal Manufacturing site or to an contract manufacturing organization (CMO).
This position should be ideally located in Boxmeer (the Netherlands) or Unterschleißheim (Germany). The position will require up to 25% international travel.
Your Key Responsibilities:
- Lead and execute analytical transfer projects (setting up and execution of transfer plans, resource needs, and timeline adherences) for both drug substance and drug products
- organize analytical activities in a pharmaceutical GMP and Quality Control (QC) environment;
- coordinate & mentor ATS (Analytical tech solutions) colleagues remotely to ensure governance of several Monoclonal Antibody projects
- Collaborates with R&D, Quality, Regulatory Affairs, external suppliers and division site responsible teams in transfer activities
- Supports strategic transfer initiatives like standardizing transfer processes and develop appropriate documentation templates
- Build up communication and trust with internal and external partners as well as stakeholders
Your Profile
- Master, Bachelor, Engineer degree and long year experience in a Pharmaceutical/Chemical/Analytical Science required
- At least 8 years’ experience in the research and development, manufacturing and testing of active pharmaceutical ingredients (APIs) or drug products required
- Experience in analytical transfer activities and broad understanding of analytical platforms like pharmaceutical analyses (chromatography and physicochemical testing, immunosorbent assays) is an advantage
- End to end understanding of pharmaceutical business relationships and the ability to work in cross functional teams, being able to create a target focused approach
- Solid experience working in international project teams
- Ability to work independently and make decisions within guidelines and policies that impact own priorities to meet deadlines
- Proficient in scientific/technical writing and current computer usage
Be part of a collaborative, international team. This position offers significant opportunities for learning and advancement.
We look forward to your application. Don't hesitate to reach out with questions.
Required Skills:
Anpassungsfähigkeit, Anpassungsfähigkeit, Aseptische Verarbeitung, Assay, Biochemische Analyse, Biochemische Assays, Chemometrik, Chromatographie, Einhaltung der GMP-Richtlinien, Fertigungsqualitätskontrolle, Funktionsübergreifende Zusammenarbeit, Gefriertrocknung, Immunoassays, Immunpräzipitation, Interkulturelles Bewusstsein, Kontinuierliche Verbesserung voranbringen, Kundenorientiert, Lean Six Sigma Prozessverbesserung, Lösung technischer Probleme, Monoklonale Antikörper, Pharmazeutische Mikrobiologie, Prozessverbesserungen, Regulatorische Compliance, Risiko-Management, Säulenchromatographie {+ 1 more}
Preferred Skills:
Current Employees apply HERE
Current Contingent Workers apply HERE
Personalberatungsvertreter, bitte sorgfältig lesen
Merck & Co., Inc., Rahway, NJ, USA, auch als Merck Sharp & Dohme LLC, Rahway, NJ, USA, bekannt, akzeptiert keine unaufgeforderte Unterstützung von Personalvermittlungsfirmen. Alle Lebensläufe, die von Personalberatungen an einen Mitarbeiter unseres Unternehmens gesendet werden, ohne dass eine gültige schriftliche Vermittlungsvereinbarung für diese Position besteht, gelten als alleiniges Eigentum des Unternehmens. Im Falle der Einstellung eines Bewerbers durch unser Unternehmen in Folge einer Agenturempfehlung wird keine Gebühr entrichtet, sofern keine entsprechende vorherige Vereinbarung besteht. Wenn Vereinbarungen mit der Agentur vorhanden sind, sind die Einführungen positionsspezifisch. Bitte keine Anrufe oder E-Mails.
Mitarbeiter-Status:
Fest angestellt
Umzug:
Visa-Sponsoring:
Reiseanforderungen:
Flexible Arbeitszeitvereinbarungen:
Hybrid
Schicht:
Gültige Fahrerlaubnis:
Gefahrstoff(e):
Job Posting End Date:
06/24/2026
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