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:
Adaptability, 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 {+ 1 more}
Preferred Skills:
