Associate Director (m/f/d) Analytical Transfer Lead

Job Description

We are excited to announce an 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 a 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, including setup and execution of transfer plans, resource needs, and timeline adherence, for both drug substance and drug products
• Organize analytical activities in a pharmaceutical GMP and Quality Control (QC) environment
• Coordinate and mentor ATS (Analytical Tech Solutions) colleagues remotely to ensure governance of several Monoclonal Antibody projects
• Collaborate with R&D, Quality, Regulatory Affairs, external suppliers, and division site responsible teams in transfer activities
• Support strategic transfer initiatives such as standardizing transfer processes and developing appropriate documentation templates
• Build communication and trust with internal and external partners as well as stakeholders

Your Profile:

• Master, Bachelor, or Engineer degree and many years of experience in Pharmaceutical, Chemical, or 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 such as pharmaceutical analyses, including chromatography, physicochemical testing, and immunosorbent assays, is an advantage
• End-to-end understanding of pharmaceutical business relationships and the ability to work in cross-functional teams with a target-focused approach
• Solid experience working in international project teams
• Ability to work independently and make decisions within guidelines and policies that impact priorities to meet deadlines
• Proficient in scientific and technical writing and current computer usage

Be part of a collaborative, international team. This position offers significant opportunities for learning and advancement.

Required Skills:

Adaptability, Aseptic Processing, Assay, Biochemical Analysis, Biochemical Assays, Cell-Based Assays, Chemometrics, Chromatography, Column Chromatography, Cross-Cultural Awareness, Cross-Functional Collaboration, Customer-Focused, Driving Continuous Improvement, Freeze Drying, GMP Compliance, Immunoassays, Immunoprecipitation, Lean Six Sigma Process Improvement, Manufacturing Quality Control, Monoclonal Antibodies, Pharmaceutical Microbiology, Process Improvements, Regulatory Compliance, Risk Management